DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.010VET |
Device Problems
Sticking (1597); Noise, Audible (3273)
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Patient Problem
Hyperglycemia (1905)
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Event Date 09/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Gtin is unavailable as the product made prior to compliance date; (b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition that the device was making a loud screeching noise was confirmed.An assessment was performed on the device which found that the device was emitting an unusual noise, and the upper trigger was sticking.During repair it was found that there was corrosion on the electric motor and emits an unusual noise, and rough rotation.It was also found that the trigger components were corroded, and the bearings and seals were worn.The assignable root causes of these conditions were determined to be due to improper cleaning and care and normal wearout.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 the small battery drive device was making a loud screeching noise.During in-house engineering evaluation it was found that the device was emitting an unusual noise, and the upper trigger was sticking.It was reported that the event did not occur during a surgical procedure.It was reported that there was no delay in a scheduled procedure due to the event.It is unknown if there was a spare device available for use.There was no human patient involvement this device is for veterinary use only.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown; however, it was noted that the event occurred sometime in (b)(6) 2016.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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