The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 while inserting a distal tibia plate, the aiming arm was missing the proximal holes.After the case it was determined that there was an issue with the aiming arm and it is possible that the right side aiming arm was either damaged/bent.Once the problem was identified, the surgery proceeded and was successfully finished.The surgery was delayed for fifteen minutes.This report is for one (1) insertn handle f/3.5mm low bnd medial distal tib plate/right.This is report 2 of 3 for complaint (b)(4).
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Product complaint (b)(4).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.H10 additional narrative: h3, h4, h6: device history lot, part: 03.113.025, lot: 9872407, manufacturing site: hägendorf, release to warehouse date: 01.Jul.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary: background: it was reported that on february 14, 2021 while inserting a distal tibia plate, the aiming arm was missing the proximal holes.After the case it was determined that there was an issue with the aiming arm and it is possible that the right side aiming arm was either damaged/bent.Once the problem was identified, the surgery proceeded and was successfully finished.The surgery was delayed for 15 minutes.This complaint involves three (3) devices.H6: investigation flow: damage / device interaction visual inspection: insrt hndl 3.5 lw bnd med dstl tib pl/rt (part# 03.113.025, lot# 9872407, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the device looks good without any damage.The surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Functional testing: complete functional testing cannot be performed at cq as all the mating devices were not returned at cq.However, the handle (03.113.025, 9872407) was assembled and disassembled with the aiming arm (03.113.001, 9290243) as intended without any issues.The bent arm might have contributed to the reported complaint condition.Unable to perform/replicated the complaint with the returned device(s).Dimensional inspection: dimensional inspection of the received device was not performed at cq as no damage was evident with the returned device.Document/specification review: the drawings were reviewed during the investigation: no design issues or discrepancies were noticed.Complaint not confirmed.Investigation conclusion: the complaint condition cannot be confirmed for the insrt hndl 3.5 lw bnd med dstl tib pl/rt (part# 03.113.025, lot# 9872407).A definitive root cause cannot be determined for the reported problem.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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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