WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY
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Model Number 03.033.001 |
Device Problems
Device-Device Incompatibility (2919); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that, during a procedure the antegrade screw hole shows damage and does not let drill sleeve trocar through along with a broken driving cap.Procedure was completed successfully without any surgical delay.No patient consequences.This report is for (1) radiolucent insertion handle frn.This is report 1 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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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.Part: 03.033.001 lot: l971715 manufacturing site: hägendorf release to warehouse date: november 15, 2018 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the radiolucent insertion handle frn (product code: 03.033.001 lot #: l971715) was received at jrz pal for investigation.The visual inspection of the received device indicated that it shows scratches and nick marks through its surface.No functional insertion test could be performed.No other issues were identified with the device.Device failure/defect identified? yes dimensional inspection: dimension specification: insertion hole diameter measured dimension: insertion hole diameter: conforming device used ¿ digimatic caliper document/specification review: current and manufactured revisoins no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed for radiolucent insertion handle frn (product code: 03.033.001 lot #: l971715).No definitive root cause could 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 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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