Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the handles on the instrument is cracked and can no longer be used in procedures.No further information is available at this time.
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Event Description
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It was reported that the handles on the instrument is cracked and can no longer be used in procedures.No further information is available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection of the returned items identified there is a crack in the handle, therefore the reported event is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event is likely to be cause by repeated cleaning and sterilisation cycles.Action resulted in a material change to the handle from radel to stainless steel.The stainless steel handle is more robust and able to withstand the cleaning/sterilisations cycles required for it to perform to its intended function.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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