SMITH & NEPHEW, INC. R3 OFFSET IMPACTOR TIP; PRSTHSS,KNEE,FMRTBL,SM-CNSTRND,CMNTD,MTL/PLYMR
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Model Number 71363077 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/20/2020 |
Event Type
malfunction
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Event Description
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It was reported that during an office inspection it was found the r3 offset impactor tip to be broken.No case involved.No injury reported.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned for evaluation.The visual inspection of the returned impactor tip confirms it fractured into two pieces.All pieces were returned.This device exhibits signs of significant use and wear.There is no lot number provided for this device.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.
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