WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPLIT TISSUE PROTECTION SLEEVE 5.0MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION
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Catalog Number 393.746 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, the handle was crooked.This report is for one (1) split tissue protection sleeve 5.0mm.This is report 1 of 1 for complaint (b)(4).
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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.H3, h6: 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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Manufacturer Narrative
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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.Visual inspection: the protect sleeve slotted f/schanz scr-ø5 (part # 393.746, lot #: unk) was received at us cq.Upon visual inspection, the drill sleeve was bent and not able to align with each other.No other issues were identified with the returned device.Device failure/defect is identified.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: since the exact manufactured date of the device was not identified, the current revision of drawings was reviewed.Complaint is confirmed.Investigation conclusion: the complaint can be confirmed.No definitive root cause can be determined based on the provided information.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 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 history lot the lot number is unknown, and therefore, dhr could not be completed.If the lot number can be confirmed, the dhr will be revisited.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4) no manufacturing record evaluation is required.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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Search Alerts/Recalls
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