Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.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 an unknown date during a tibial plateau leveling osteotomy, the thread on one of the locking self-tapping holes (caudal head of plate) was not threaded right or cross threaded.The lst screw drill guide was not able to screw into one of those holes.3 tplo plates were opened, and all were the same.There was an unknown surgical delay.The procedure was successfully completed.There were no patient consequences.Concomitant device reported: unknown - drill guides: (part# unknown; lot# unknown; quality:1), unknown - screw: (part# unknown; lot# unknown; quality: unknown).This complaint involves five (5) devices.This report is for (1) 3.5mm tplo plate/right 3 holes.This report is 2 of 5 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.A1, a2, a3, a4: device used in a veterinary case - no patient information will be reported.H3, h4, h6: part #: vp4401.R3, synthes lot #: 98p7454, supplier lot #: 98p7454, release to warehouse date: 19 mar 2021, supplier: (b)(4), no ncr's generated during production.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.Visual inspection: the 3.5mm tplo plate/right 3 holes (part# vp4401.R3, lot# 98p7454) was returned and received at the jabil elmira manufacturing facility.A visual inspection of the device shows the plate appears to be in the same acceptable conforming condition cosmetically as it was when it shipped from the jabil elmira manufacturing facility.Device failure/defect identified? no.Dimensional inspection: thru hole (feature d2) result: pass.Thread pitch diameter (feature h7) result: pass.Thread minor diameter (feature d7) result: pass.Ball mill depth (feature h1) result: pass.Document/specification review: no design issues or discrepancies were found during this investigation.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for 3.5mm tplo plate/right 3 holes (part# vp4401.R3, lot# 98p7454).A definitive root cause could not be identified for the reported problem.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.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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