SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PRSTHSIS,HIP,SM-CONSTRAINED, UNCMNTD,MAL/PLYER,NON-PROS, CLICUM-PHSPHT
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Model Number 71365705 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/10/2020 |
Event Type
malfunction
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Event Description
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It was reported during surgery the inserted broke while inserting the implant.A backup device was available to complete the procedure.
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Manufacturer Narrative
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The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
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