H3, h6: it was reported that during a total hip replacement surgery the polarstem collar calcar reamer small was dull and fractured patient´s calcar.The device, used in treatment, was returned for investigation and a visual inspection was performed.The returned instrument is in a good condition and only slight signs of use such as superficial scratches are observed.The cutting teeth are still very sharp.A review of the complaint history of the affected device was performed.Two additional complaints for the batch in scope were detected with a similar reported failure mode.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.There is no indication that the reported device failed to meet manufacturing specifications upon release for distribution.A review of past corrective actions was performed.No further escalation is required.A risk management review for bone fracture in combination with the use of a calcar reamer was performed within a preliminary risk assessment in aug.2021.According to this, the performance of the device is within the risks that are anticipated in the risk management documentation of the product, both in occurrence and severity.As no medical documents have been provided regarding the femoral bone fracture, no review could be conducted.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.The calcar reamer device has been observed to lead in some rare cases to calcar fracture.There is another instrument with shorter teeth, that may be more appropriate to the expectation of the surgeon.Based on the performed investigations, the relationship between the reported event and the device could be confirmed.Nevertheless, the root cause of the reported intra-operative calcar fracture cannot be determined conclusively.It is however recommended, to first bring the reamer in motion/spinning before touching down on the bone for reaming.Should more information become available, the investigation will be reopened.No further actions are deemed necessary at this time.The continued performance of the device shall be monitored through standard post market surveillance review processes.Smith and nephew will continue to monitor this device for similar issues.The returned part will be discarded.
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