SYNTHES GMBH BATTERY RECIPROCATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.715 |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The reporter's phone number was not available.Udi: (b)(4).
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the battery reciprocator device was intermittently on and off and could sometimes not be used.There were no delays to the surgical procedure and the procedure was completed successfully.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the battery reciprocator device would not run and had seized gear.It was further determined that the device failed pretest for check function of device and check oscillation frequency with frequency meter.The assignable root cause was determined to be due to component failure from normal wear.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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