DEPUY SYNTHES PRODUCTS LLC SAGITTAL SAW ATTACHMENT FOR TRS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 05.001.223 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.(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 the locking latch of the sagittal saw attachment device was dismantled from the device.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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Additional narrative: 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 bearing of the attachment device was not functioning and was defective.It was noted that the bearing was damaged.It was further determined that the device failed pretest for check the saw performance, check the oscillation frequency, check the free movement, and check the quick coupling for saw blades.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper 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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