WRIGHTS LANE SYNTHES USA PRODUCTS LLC HYBRID INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 03.037.011 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant device/part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested and is currently pending completion.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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Event Description
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It was reported that on (b)(6) 2021, the driving cap/threaded snapped off into the hybrid insertion handle during insertion of proximal femoral nailing system (tfna).There was a five minutes surgical delay.The procedure was successfully completed.There was no patient consequence reported.Concomitant device reported: unknown proximal femoral nailing system (tfna) (part# unknown, lot# unknown, quantity 1).This complaint involves two (2) devices.This report is for one (1) hybrid insertion handle.This report is 1 of 2 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part: 03.037.011.Lot: l862522.Manufacturing site: hägendorf.Release to warehouse date: 30 july 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the hybrid insertion handle (part #: 03.037.011, lot #: l862522) was received at us customer quality (cq).Visual inspection of the complaint device showed no damage or defects.Functional test: a functional assessment was not able to be performed as the tip of the mating device was broken and stuck inside the insertion handle.The complaint was unable to be replicated.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage on the mating device.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the damage from the mating device prevented the two devices from assembling correctly.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.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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