This complaint is recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the wiring was damaged (no exposed wiring), the motor speeds were low, and the device was out of calibration.The motor, switch, reciprocating arm, plug harness, spring seal, bearings, and strain relief were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event is 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.E1 telephone number: (b)(6).G2 country: singapore.
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It was reported that outside of surgery the device was sent in for preventive maintenance, annual calibration and the electric wire has a visible cut and is damaged.There was no wire exposed nor metal seen.There was no patient involvement.During product evaluation, it was found that the motor speeds were slow.Due diligence is complete and there is no additional information available.There was no adverse event associated with the malfunction.
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