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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(64), 2021, the patient underwent open reduction internal fixation surgery for distal radius fracture.Before the surgery, the surgeon checked the attachment of the plate in question to the drill sleeve (03.114.001).The drill sleeve, which is normally wearable, was idling and could not be attached only to the right hole of the plate t-shaped part.The surgery was completed without any surgical delay.The patient outcome was unknown.No further information is available.This complaint involves two (2) devices.This report is for (1) 1.5mm lcp condylar plate 6 hole shaft.This report is 1 of 2 for (b)(4).
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Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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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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.H3, h6: part number: 02.114.014, lot number: h439390, part manufacture date: 06-sep-2017, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 1.5mm lcp condylar plate 6 hole shaft product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that locking cond pl 1.5 shaft 6ho he 2ho sst the plate was having slight scratches and no issues were identified.The dimensional inspection was not performed for the locking cond pl 1.5 shaft 6ho he 2ho sst due to alleged complaint condition.The functional test was not performed since the device was received by itself.The observed unable to assemble of the components is not consistent with the complaint condition since the functional test cannot be performed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for locking cond pl 1.5 shaft 6ho he 2ho sst.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that 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.Drawing/specifications reviewed? the following drawing reflecting the current and manufacture revision was reviewed: 1.5 mm condylar plate 1.5 lcp modular mini frag.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.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 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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