The reported event could be confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received clamp overall showed normal signs of usage.However, one of its legs was found broken.The breakage pattern on the surface of the broken leg indicates typical brittle breakage under high bending load.No plastic deformation was observed around the breakage point, indicating towards an instantaneous breakage under a high load.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is user related.The breakage of one of the legs of the clamp occurred due to intra-op excessive bending load application on the leg leading to an instantaneous breakage.If any further information is provided, the complaint report will be updated.
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