OBERDORF SYNTHES PRODUKTIONS GMBH OSCILLATING SAW ATCH, LARGE, WITH KEY; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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Catalog Number 532.026 |
Device Problems
Output below Specifications (3004); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported that during a veterinary tibial plateau leveling osteotomy (tplo) procedure on an animal, it was observed that the cutting action on the oscillating saw attachment device slowed down and made a grinding sound.According to the report, the event occurred when the saw blade device was connected to the device and was tried to cut the bone.There was an unspecified delay there was a delay to the surgical procedure as a spare device was retrieved.There was no human patient involvement as this was a veterinary procedure.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.Correction: concomitant medical devices: the date device returned to manufacturer was documented as 3/6/2018 in the initial report.It has been updated as this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the bearing was seized, jammed and moving heavily.Therefore, the reported condition was confirmed.It was further determined that the needle bearing was blocked, device had too little power and grinding noise.It was further determined that the device failed pretest for check frequency.10800 to 13200 osc/min.The assignable root cause could not be determined.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.Correction: the date device returned to manufacturer was documented as 3/12/2018 in the initial report.It has been updated as 3/08/2018.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Search Alerts/Recalls
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