WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY
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Model Number 04.037.042S |
Device Problems
Failure to Cut (2587); Device-Device Incompatibility (2919)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was 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 canada reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for im nailing of proximal femur fix.During the procedure, locking mechanism does not fully seated.Prong most likely did not have enough space to pass into between groove in blade and inside wall of tfna nail.The procedure completed successfully.There was no patient consequence.Concomitant device reported: 5.0mm ti locking screw w/t25 stardrive 34mm f/im nail-ster.(part# 04.005.524s; lot# 54p3760; quantity: 1).This complaint involves 2 devices.This report is for (1) unk - screws: trauma.This is report 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.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.The device was not returned.A photo-investigation was performed on the images.No device issues were noted.It was apparent in the images that tfn helical blade was used; the implanted nail had similar features to the tfna nail family.The insertion handle appeared to be connected to the nail, and the locking mechanism appear to be in the unlocked position.No device issues were noted.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion the complaint condition was confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.The assembly issue was attributed to the use of two incompatible devices used together by the user.No device issues were observed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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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