DEPUY SYNTHES PRODUCTS LLC QUICK COUPLING FOR K-WIRES; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.022 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.The actual device was returned for evaluation.The quick coupling device was evaluated and the reported condition was confirmed.An assessment was performed and it was observed that the coupling guide came apart from the housing.During repair, it was observed that the components of the device were corroded.The assignable root causes of these conditions were determined to be improper cleaning, which is user error/misuse/abuse, and normal wear over time.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported that the quick coupling device had an undetermined malfunction.During in-house engineering evaluation, it was observed that the coupling guide came apart from the housing.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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