SYNTHES GMBH BATTERY RECIPROCATOR II FOR BPL II; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Model Number 530.715 |
Device Problems
Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the saw plane was unable to be adjusted on the battery reciprocator device.During in-house engineering evaluation, it was observed that the trigger was sticky.It was further determined that the device would not run, could not secure/lock the cutter, and had fluid ingress.It was observed that the saw head could not be rotated or locked in the new position.It was further determined that the device failed pretest for check the quick coupling for saw blades check positioning of saw head, check for sticky trigger, check function of device and check oscillation frequency with frequency meter.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.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.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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the sticky trigger, identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to user, which is user error.Udi: (b)(4).
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Search Alerts/Recalls
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