Medical device manufacturer, Synthes GmbH, has issued a medical device labeling update concerning its T-PAL, Technique Guide [Part No.: 036.001.088; Updated Revision AD; Outdated Revisions: AA, AB, AC].
The manufacturer updated the T-PAL Technique Guide (PN 036.001.088) on page 19, 21 and 47 to clarify instrument handling of the T-PAL applicator (PN 03.812.001 Applicator Outer Shaft, PN 03.812.004 Applicator Knob). Faulty handling of the T-PAL applicator instrument potentially contributes to failure of the Applicator Inner Shaft (PN 03.812.003) during insertion of implants or the non-detachable T-PAL Trial implants (PN 03.812.307-317 and 03.812.507-517).
According to the manufacturer, if the Inner Shaft should break, the trial (or implant) spacer will no longer be secured in the 0o position. This rigid position is necessary for insertion; in the pivoting position, the assembly cannot be properly advanced into the disc space. Furthermore, loss of rigidity during advancement of the trial (implant) into disc space could result in loss of tactile control by the surgeon. This failure is known to have resulted in a significant surgery delay and minor vascular injury. Depending upon the stage of surgery, if the failure were to occur the potential harms in a worst case scenario could be:
The manufacturer has not had any complaints of the above-mentioned events to date.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 01 Aug 2014