WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS; GAUGE,DEPTH
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Catalog Number 03.010.428 |
Device Problem
Break (1069)
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Patient Problems
Foreign Body In Patient (2687); No Code Available (3191)
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Event Date 11/29/2019 |
Event Type
Injury
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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.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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It was reported that on (b)(6) 2019, during a proximal femoral nailing system (tfna) hip fracture procedure, a metal tip of a depth gauge broke apart inside the patient.It was unretrievable.There was no surgical delay.Procedure was successfully completed.Patient status is unknown.This complaint involves one (1) device.This report is for one (1) depth gauge for locking screws to 100 mm for im nails.This is report 1 of 1 for (b)(4).
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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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.Complainant part is not expected to be returned for manufacturer review/investigation.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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