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: manufacturing location: (b)(4).Manufacturing date: 28-jun-2021.Expiration date: 31-may-2031.Part number: 04.037.055s, 10mm/130 deg ti cann tfna 340mm/left ¿ sterile.Lot number: 231p190 (sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final, nonconformance review met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, nonconformance review met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn supplied by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿surgeon perforated the femoral neck with the helical blade¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review: this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that 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 (15) minute surgical delay.The procedure was successfully completed with no patient consequences.This report is for (1) 10/130 deg ti cann tfna 340/left - sile.This is report 2 of 2 for (b)(4).
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