The reported event that k-wire, smooth, 1.4mmx100mm was alleged of issue s-11 (breakage during surgery) could not be confirmed, since the device returned for evaluation did not match the alleged failure mode.The product was returned for evaluation; however, during visual inspection, it was found to be in perfect condition.Both ends of the product was found to be in good condition.Considering the nature of the returned product and the alleged complaint, functional and dimensional inspection was not considered necessary.The device history record could not be reviewed as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.
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