WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY
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Model Number 03.033.001 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: initial reporter is a j&j employee.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.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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On (b)(6) 2022, it was reported that when striking the threaded driving cap to insert the frn, the threaded portion of the driving cap broke off into the insertion handle.There was patient involvement.No surgery delayed due to the reported event.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.This report is for one (1) radiolucent insertion handle frn.This is report 1 of 2 for complaint (b)(4).
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Search Alerts/Recalls
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