DEPUY SYNTHES PRODUCTS LLC SMALL BATTERY DRIVE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Model Number 532.110 |
Device Problem
Noise, Audible (3273)
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Patient Problem
Not Applicable (3189)
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Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
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Event Description
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It was reported that the prong inside the small battery drive device casing that plugs into the battery sleeve felt loose and was spinning.It was further reported that the device made an audible rattle.It was not reported if the device was used in surgery.There was no human patient involvement as this device is intended for veterinary use only.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown.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 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation. quality engineering evaluated the device and it was determined that the reported condition was not confirmed.However during evaluation, it was noted that there were traces of liquid on top of the motor and the holding tube was corroded.It was further reported that the device passed all pretesting diagnostic assessments.The assignable root cause of the corrosion and liquid was traced to improper maintenance.
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