It has come to our attention that medical device manufacturer, Synthes, has initiated a field safety corrective action concerning its Drill Bit 2.0mm drilling depth 14mm, 3-flute, for Quick Coupling (Part no.: 03.617.914; Lot no.: 8496070).
It was discovered that a product of the above mentioned lot of 2.0 mm Drill Bits with 14mm Stop/ Zero-P had been manufactured with a tip that was 16mm. This 16mm component was then incorrectly packaged, labeled, and distributed as a 14mm drill bit.
If the non-conforming drill bit passed unrecognized into the operation room and to the surgeon for use, the longer than intended drill bit could potentially penetrate the posterior wall of the vertebral body. This could potentially result in minor bone, soft tissue or disc damage or, in a worst-case scenario, damage to the spinal cord, meninges, or nerves with the potential for permanent injury. If a dural tear occurred intraoperatively, the necessary repair might lead to a significant lengthening of the surgery.
The manufacturer advises users to quarantine and return the affected products.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 18 November 2014