It was reported that, during total hip replacement, a plus sl-plus mia dbl offset adapt.Right 60/25mm broke on impaction, inside the patient.All parts were retrieved by hand.Surgery was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
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H3, h6: it was reported that, during total hip replacement surgery, a plus sl-plus mia dbl offset adapt.Right 60/25mm broke on impaction, inside the patient.The device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.The clutch is broken.Apart from that, the device shows normal signs of usage such as gouges and dents.A complaint history review was performed.One additional complaint with the batch in scope was reported so far.A review of the batch record revealed no deviations from the standard manufacturing process, that could have contributed to the reported issue.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.Upon performed medical investigation, no patient injuries or adverse consequences were reported.Therefore, no further clinical/medical assessment is warranted at this time.The failure mode and the severity are covered in the corresponding risk management document.A review of past corrective actions was performed.No further escalation is required.However, based on the performed investigations, the relationship between the reported event and the device was confirmed.This instrument is designed to hold and guide the detachable rasps for broaching.It is therefore subjected to repeated impact forces via the modular knock plate or the pneumatic woodpecker.Previous investigations demonstrated, that under specific circumstances, this device may fracture during impaction.An optimized design of the device has been released in order to reduce the occurrence of this issue.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.This version of the device will be monitored for similar issues.The returned device will be discarded.
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