ZIMMER SURGICAL, INC. HANDPIECE, ELECTRIC DERMATOME; DERMATOME HANDPIECE, ELECTRICALLY-POWERED
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Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the rmps were in specification on the low end, but erratic.The motor, switch, spring seal, and plug harness assembly were replaced and resolved the issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It is confirmed the device needed repair.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that during an unknown time, the device has an unknown issue.There was no patient harm or delay noted.During product evaluation, it was found that the rpms were in specification on the low end, but were erratic.Due diligence is complete and there is no additional information available.
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Search Alerts/Recalls
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