It was reported that, during a thr surgery, a polarcup trial insert nav 22/47 was noticed to be cracked.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.
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H3, h6: it was reported that, during a thr surgery, a polarcup trial insert nav 22/47 was noticed to be cracked.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.The complaint device, used in treatment, was not returned for investigation.The reported issue could not be confirmed.A review of the batch record revealed no deviations from the standard manufacturing process.A review of the complaint history revealed no additional complaint for the batch in question.A review of the risk management documentation verifies the failure mode and severity of the reported issue.No prior escalation actions are related to the reported issue.Based on the performed investigations, the reported failure mode could not be confirmed.A relationship between the reported event and the device cannot be confirmed.The reported device met manufacturing specifications upon release for distribution.No probable cause can be determined.Normal wear and tear through repeated use is known to contribute to the reported event.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.This version of the device will be monitored for similar issues.This investigation is considered closed.Should the complaint device become available, the complaint will be reassessed.
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