SMITH & NEPHEW ORTHOPAEDICS AG. POLARSTEM COLLAR CLACAR REAMER SMALL; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
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Catalog Number 75102207 |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 07/16/2019 |
Event Type
Injury
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Event Description
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It was reported that during surgery, while reaming the calcar by using the calcar reamer, the femoral bone was broken.
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Manufacturer Narrative
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It was reported that while reaming with the calcar reamer, the femoral bone broke.The affected reamer guide and the corresponding calcar reamer were returned for investigation.The returned instruments are in a good condition and only slight wear patterns are observed.A functional evaluation performed with the returned two devices showed, that once the reamer guide is mounted on a rasp, the calcar reamer can freely spin around the reamer guide.As no medical documents have been provided, regarding the femoral bone fracture, no review could be conducted.Based on the performed investigation, the root cause of the reported intra-operative femoral 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.The continued performance of the device shall be monitored through standard pms review processes.Smith&nephew will continue to monitor this device for similar issues.The returned parts will be archived.
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