SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PRSTHSS, HP, SM-CNSTRND, UNCMNTD, MTL/PLYMR, NN-PRS, CLCM-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 11/11/2019 |
Event Type
malfunction
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Event Description
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It was reported that during revision surgery the threaded portion of the instrument broke off into the implant stem.No back-up available.Delay under 30 min.
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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 review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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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