(b)(4).Concomitant medical device - biomet microfxation traumaone system contra angle cross-drive blade catalog #: sp-2379, lot: 797520.Therapy date: (b)(6) 2018.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00109 and 0001032347-2018-00111.
|
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and part of the reported event was confirmed.A visual inspection of the returned drivers shows good overall condition for all three (3) drivers; there are minor scratches on all but no significant discoloration.The returned blade shows normal signs of use.Of note, the blade was returned disengaged from the drivers.The returned blade was successfully inserted into the collet and removed from all three (3) returned drivers, therefore the portion of the complaint that two (2) of the returned contra angles having blades that would get stuck irreversibly is unconfirmed.The most likely underlying cause cannot be determined.Functional testing was performed with the returned parts to drive a 2.4 x 16 mm screw(part # 73-2416) into a block of poplar wood.The driver with lot 727930 was able to turn the blade and insert the screw; lots 329420 and 008100 were not able to turn the blade and insert the screw, while there was also clicking heard.Lots 329420 and 008100 were disassembled for further investigation and inspection; it was noted that the internal gears were stripped and there were metal shavings during disassembly.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the gears being stripped, likely a result of excessive force from over torqueing by the surgeon.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00109-1 and 0001032347-2018-00111-1.
|