Unknown date in 2018.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.(b)(4).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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Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent a revision surgery to fix a sub-trochanteric fracture on (b)(6) 2018.The patient's initial surgery was six months ago on an unknown date in 2018.In between three and six months post-op, the patient fell three times.After the third time, the patient started to feel pain in the hip.When the patient was checked in the hospital, x-ray showed that one (1) trochanteric femoral nailing system advanced (tfna) nail, and one (1) titanium (ti) tfna fenestrated screw were broken.The patient was revised with a new tfna nail and blade.The surgeon believes the breakage was due to the falls.There was no reported surgical delay.The procedure was completed successfully with the patient in stable condition.Concomitant device: distal locking screw (part# 04.005.530, lot# l723843, quantity# 1).This report is for one (1) 11mm/125 deg ti cann tfna 200mm - sterile.This is report 1 of 2 for (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history records review was completed for part: 04.037.113s, lot: h474636.Manufacturing location: monument, manufacturing date: oct 17, 2017, expiry date: oct 01, 2027.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.Product investigation was completed.The 11mm/125 degree ti cannulated tfna 200mm (04.037.113s) was received cracked at the head element proximal locking hole.Additional surface wear consistent with implantation and explantation was noted which would not impact device functionality.The received condition of the device was found to sufficiently match the complaint description of broken as the device was cracked, as such the complaint is confirmed.Based on the complaint description the patient had multiple post-operative falls which the surgeon felt contributed to the device failure, as such a root cause related to postoperative trauma was determined.The diameter of the proximal nail, adjacent to the fracture was measured at 15.67mm above the fracture and 15.68mm below the fracturing using calipers ca301.Both measurements are within the specification of 15.66 +/- 0.1mm.Relevant drawings, reflecting the current and manufactured revisions, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned nail was found to be cracked at the proximal head element hole, as such the complaint is confirmed.The system risk document was found to adequately address the complaint condition.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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