Catalog Number 225137 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the bone reduction forceps 51/2 w/ratchet (225137) broke during an orthopedic procedure, the operating room (or) team took an item from a replacement kit in order to proceed with the procedure.Staff had to perform a scan to make sure no parts were left before they closed the area.It was reported that the exact increase in procedure time was unknown but estimated 30-60 minutes.No patient injury has been reported.
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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The bone reduction forceps 51/2 w/ratchet (225137) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: visual evaluation of the forceps noted the unit was returned in used condition.Wear was visible on the surface of the handles.Root cause analysis: the reported complaint was confirmed.Sales records indicate that this lot number was last sold in (b)(6) 2022.It was determined that the returned forceps had one of the tips broken off due to wear or rough handling.No manufacturing, workmanship or material deficiency has been identified.
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Event Description
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N/a.
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Search Alerts/Recalls
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