DEPUY SYNTHES POWER TOOLS QUICK COUPLING FOR K-WIRES; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.022VET |
Device Problems
Corroded (1131); Difficult to Insert (1316)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device would not hold the smallest wire, would not run smoothly and ran untrue.A visual and functional assessment was performed on the device which found that the unit failed the general condition check, cannulation check, self-holding check, smooth running check, untrue running check and gripping power and function check.During repair it was observed that there was an unknown brown substance between the slid-sleeve and housing.It was further determined that there was unknown brown substance on the slid-sleeve and the guide-sleeve and clamps were corroded.It was further determined that these issues were consistent improper cleaning.Therefore, the reported condition was confirmed.The assignable root causes were determined to be due to improper cleaning methods.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 during an unspecified veterinary surgical procedure, it was observed that rust seemed to be coming out of quick coupling device.It was further reported that there was an issue getting a pin into the device.There were no delays to the surgical procedure as a spare device was available to complete the surgery successfully.There was no human patient involvement as the device was used in a veterinary procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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