Model Number N/A |
Device Problems
Material Frayed (1262); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that when the device was undergoing processing following a clinical procedure, the outer black insulation cable was detached at the point it inserts into the handpiece leaving the inner wires exposed.There was no patient harm or injury reported.Due diligence is complete, no further information available.
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.E1: telephone: (b)(6).G2: foreign: united kingdom.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined there were no signs of cable damage or exposed wiring.The motor speeds were unstable and the motor was corroded.The motor was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event cannot be confirmed.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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No additional event information available.
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Search Alerts/Recalls
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