It was reported that during a field inspection a polarcup trial insert nav 22/63 was found to be cracked.No case involved.The device use in treatment was returned for investigation.The reported failure mode could be confirmed upon visual inspection.The device is observed to be fractured.A review of the complaint history revealed no additional complaint for the batch in question.A review of the batch record does not indicate that the device failed to match specification at the time of manufacturing.The device was manufactured in 2011.Based on the performed investigations, the reported damage could be confirmed.The relationship between the reported event and the device was confirmed.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Normal wear and tear through repeated impaction are known to contribute to the reported event.Additionally, repeated steam sterilization processes could contribute to an embrittlement.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all devices must be inspected and controlled for proper functioning after cleaning/disinfection.It is unknown for how many cycles this instrument has been used.Therefore, the root cause stays undetermined after investigation.The need for corrective action is not indicated.Nevertheless, smith + nephew will continue to monitor the device for similar issues.The returned device will be discarded.
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