DEPUY SYNTHES POWER TOOLS OSCILL-SAW-ATTACHM F/532.001 532.010 532; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.021 |
Device Problems
Partial Blockage (1065); Mechanical Problem (1384); Physical Resistance (2578); Mechanical Jam (2983)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: (b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.An assessment was performed on the device which determined the mechanics swing fork was blocked.It was further noted that the mechanics seized, jammed and were heavy moving.The assignable root cause was determined to be due to wear from normal use and servicing over time.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 from (b)(6) that the oscillating saw attachment device was jammed.The reporter stated there was an issue with the bearing of the device.During in-house engineering evaluation it was found that the mechanics swing fork was blocked and the mechanics seized, jammed and were heavy moving.It was not reported if the device was used in surgery, or if there was patient involvement.There were no delays to a scheduled surgical procedure.A spare device was not available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this 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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Search Alerts/Recalls
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