Important Safety Alerts

Medical device manufacturer, DePuy Synthes, has issued a medical device safety alert concerning its CORAIL AMT Neck Trials Surgical Instruments. The affected devices are identified as below:

• Part Description: A) CORAIL AMT NECK SEG 135D SHORT; B) CORAIL AMT NECK SEG 135D KHO; C) CORAIL AMT NECK SEG 135D STD; D) CORAIL AMT NECK SEG 125D KLA; E) CORAIL AMT NECK SEG 125D STD
• Part Number: A) L94007; B) L94006; C) L94005; D) L94004; E) L94003
• Lot Number: All lot

The manufacturer addressed the potential for debris/material to be found behind the O-Rings for some CORAIL Neck Trials.

According to the manufacturer, twelve complaints were received related to debris behind the O-Ring. It has evaluated the issue and determined that none of these complaints have resulted in patient harm and found no increased risk to the patients.

As a precautionary measure, the manufacturer determined that reworking the affected devices and removing the O-Rings is the appropriate corrective action. The function of the device is unaffected by this change as the manufacturer currently markets products of the same design (i.e. without an O-Ring).

The affected users are advised to take the following actions:

• Continue to follow the instructions for use in IFU-W90946 Rev B regarding cleaning of these devices;
• Medical facilities are to determine if any of the affected instruments are on hand, and contact their Sales Consultant to arrange for rework or replacement of these instruments;
• Notify surgeons at their facility by providing them with a copy of the notice to ensure surgeons are aware of the Field Safety Notice.

According to the local supplier, the affected product Part Number: L94007, is distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 29 May 2018