Catalog Number CAT02462 |
Device Problem
Sticking (1597)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that during hip arthroscopy labral repair, the doctor successfully implanted cinchlock ss anchor.When the doctor pulled handle to deploy cinchlock and as pulled out pull wire was still engaged and stuck in anchor; there was no difference in resistance to remove the handle than during other uses of cinchlock ss.The doctor used a suture cutter to cut the pull wire flush with the anchor.This resulted in an extra 10 minutes to the case.No injury to user or patient.Two implants were opened at the beginning of the case, but only the anchor reported in this event was used.
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Manufacturer Narrative
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(b)(4).The device manufacture date is not known device was not returned for evaluation to confirm lot number.Alleged failure: pull wire stuck in anchor.Probable root cause: design: poor mechanical advantage of locking feature.Materials of inserter locking mechanism cannot withstand user locking forces.Manufacturing: locking mechanism not manufactured or assembled to specification.Incorrect heat treatment applied.Application: not enough force applied.User unfamiliarity with device.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported that during hip arthroscopy labral repair, the doctor successfully implanted cinchlock ss anchor.When the doctor pulled handle to deploy cinchlock and as pulled out pull wire was still engaged and stuck in anchor; there was no difference in resistance to remove the handle than during other uses of cinchlock ss.The doctor used a suture cutter to cut the pull wire flush with the anchor.This resulted in an extra 10 minutes to the case.No injury to user or patient.Two implants were opened at the beginning of the case, but only the anchor reported in this event was used.
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Search Alerts/Recalls
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