SYNTHES OBERDORF BATT-HANDPIECE RECON SAGITTAL SAW W/T-HA; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 05.001.240 |
Device Problem
Difficult To Position (1467)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).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.
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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 saw devices did hold very well on the battery handpiece device.It was reported that there was no delay in the procedure due to the event as the same device was used to complete the procedure.There was patient involvement reported.There were no reports of 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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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The device was evaluated and it was determined that the coupling tool side was not functioning and was defective.It was noted that the tool coupling was defective.It was further determined that the device failed pretest for check the saw blade coupling, and check for leakage.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper cleaning and maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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