DEPUY SYNTHES PRODUCTS LLC BATTERY HANDPIECE/MODULAR FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 05.001.201 |
Device Problem
Unintended Ejection (1234)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).Concomitant device: lid device.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Event Description
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This is event 1 of 2 of the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the lid device came out of the battery handpiece device after it was closed.There was a fifteen minute delay in the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the housing was worn and the device failed pretest for check for leakage.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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