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Catalog Number 03.010.404 |
Device Problems
Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2021 |
Event Type
malfunction
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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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the threads on the cannulated connecting screw appear stripped, making it difficult to remove connect or disconnect from nail.Protection sleeves were jammed in the protection sleeve handle and are very difficult to disassemble.Concomitant devices reported: unk - nails(part# unknown, lot# unknown, qty unknown).This report is for (1) connecscr cann f/etn f/suprapatellar app.This is report 5 of 5 for complaint (b)(4).
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Search Alerts/Recalls
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