Investigation results were made available.Review of event description: it was reported that the dynesys blade has been worn out.There was a surgical delay of 40 min and surgery was performed using a scalpel.The event happened on (b)(6) 2020.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed as only the complained product is known.Conclusion: it was reported that the dynesys blade has been worn out.There was a surgical delay of 40 min and surgery was performed using a scalpel.The event happened on (b)(6) 2020.No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the part is unknown.No pictures of the device were received.The lot number of the device is also not available to check the manufacturing records and material certification.Based on the investigation the reported event cannot be confirmed.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
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