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Catalog Number 03.130.270 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.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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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for an unknown surgery.During the surgery, when performing cutting procedure, the plier was broken.There was no fragment generated.The surgery was completed successfully with 10 minutes delay.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) unk - plates.This is report 1 of 1 (b)(4).
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Manufacturer Narrative
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Product complaint # pc-(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: b5: updated information.D10: 2/18/2021: updated concomitant devices reported.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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Event Description
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2/18/2021: updated concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity # 1).
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Manufacturer Narrative
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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 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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Manufacturer Narrative
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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.H10: additional narrative: h3, h4, h6: part 03.130.270, lot t137097: manufacturing site: tuttlingen.Release to warehouse date: december 08, 2016.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the distal tip of one of the jaw was broken and the broken fragment was returned.The device was missing the plate holder component.No other issues were observed with the returned device.No dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed as the device was broken and missing a component.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause for broken condition could be due to unintended forces applied to the device.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.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.H11: corrected data: d10.
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Search Alerts/Recalls
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