It was reported that there was an issue with the product bd511r - adson tissue fcps fine w/1x2t 120mm.According to the complaint description, the teeth broke off while grasping tissue during orthopedic surgeries.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aesculap ag reference no.(b)(4) ( aesculap ag reference no.(b)(4)).Associated medwatch-reports: 9610612-2024-00113 (internal aesculap ag ref.No.(b)(4)- bd511r).9610612-2024-00114 (internal aesculap ag ref.No.(b)(4)- bd511r).9610612-2024-00115 (internal aesculap ag ref.No.(b)(4)- bd511r).
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Investigation results: visual inspection: the teeth on two (2) products were broken off.For product three (3), no product was returned.Hardness test: actual: 491, 488 (hardness according to vickers) hv5; target:400+100.Device history review: the device quality and manufacturing history records have been checked for all available lot numbers and the products were found to be according to our specification valid at the time of production.There are no other similar complaints within these batches.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered eportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Conclusion/preventive measures: based upon the above-mentioned investigation results, a definitive root cause cannot be established.There are no hints for a material failure, as the hardness is according to the specification; and a product related failure is also excluded.
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