Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: part # 04.038.375s, synthes lot # h566892, supplier lot # n/a, release to warehouse date: 12 apr 2018, expiration date: 31 mar 2028, manufacturing location: (b)(4), no ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that on (b)(6) 2021, during an unknown procedure, while inserting a tfna nail, the surgeon perforated the femoral neck with the helical blade.The nail and helical blade were extracted, and reinserted.The helical blade was repositioned in the femoral neck and the surgery was completed successfully.During extraction, one of the prongs of the connection interface was slightly bent; however the nail was successfully reconnected and inserted.There was a fifteen (15) minute surgical delay.The procedure was successfully completed with no patient consequences.This report is for one (1) tfna fenestrated helical blade 75 - sile.This is report 1 of 2 for (b)(4).
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