DEPUY SYNTHES PRODUCTS LLC BATTERY RECIPROCATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.715 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).The serial number was unknown.The manufacturing location was unknown.The device manufacture date is unknown.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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It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the battery reciprocator ceased to function immediately during operation.According to the reporter, the device worked during operation check, however stopped immediately.The battery device was changed and blade device was checked by the user, however the situation remained.There were no reports of delays in the surgical procedure.It was reported that the surgery was completed using an oscillator saw blade device.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.D4: the device serial number was reported as unknown in the initial report.The serial number and udi have been updated accordingly.Udi: (b)(4).D11: concomitant med products: battery devices g2: the manufacturer location was documented as unknown in the initial report.The location has been updated to oberdorf.Contact office name/address has been updated accordingly to reflect the correct manufacturing facility.H4: the date of manufacture was reported as unknown in the initial report.The date has been updated to 02/11/2016.H10: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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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.H10: this device was returned for evaluation; however, during pre-repair assessment, it was determined that the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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