It was reported that there was an issue with nf952r - acetabular reamer head standard d52mm.According to the complaint description, after reaming with the correctly chosen size, the 52mm cup did not fit.Next, the 54mm trial was fit in place, and the 54 mm plasma cup was implanted instead.It was noted that the 54mm reamer had not been used.There was an additional medical intervention.A larger cup than originally planned was implanted in the patient.Additional information was not provided.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: nf950r - acetabular reamer head standard d50mm (b)(4).
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Investigation: visual investigation: the two (2) reamers were sent to the mc department for investigation and functional check.Result: there are no deviations regarding size/dimensions on both reamers.The cutters are relatively old with partly blunt/damaged, depressed cutting edges.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 2/3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale no failure regarding size/dimensions on both reamers could be determined.Suspected size discrepancy of profiler cannot be confirmed.Most probably, the larger milling in the acetabulum during application was caused by the increased force due to the damaged/blunt cutting edges.Therefore,extract from instructions for use (ifu) applies; after each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and free of damage (e.G.Broken insulation or corroded, loose, bent broken cracked, worn, or fractured components).Massive rotational movements to remove material could have additionally intensified this.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigation results, a capa request is not necessary.
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