It was reported by the healthcare professional to the company sales representative "the jaws of the device are not holding, the shaft of the device is moving." the event occurred during surgery.It was reported that there was no delay in surgery, no harm to the patient and no additional intervention needed.
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Investigation: reviewed all previous complaints ytd for similar reported events across all similar part numbers.No similar events reported.Reviewed dhr to verify all steps were completed in accordance with the pcp.All steps were completed.Verified the final audit over inspection by a qe was performed prior to shipment which included a 20 piece over inspection, which meets the defined 15 piece minimum.Reviewed training records of individuals responsible for the assembly process of this lot.Records reflect individuals were properly trained in the assembly process.Visual inspection: the returned device was missing the screw cap.The glue surrounding the screw also shows evidence of having been manipulated post cure.The cured glue around the set screw shows evidence of being loosened, as shown by the displacement separation of the glue from the rotator housing, peeling, flaking, glue surface damaged and torn.As a result of the loosened set screw, it is not fully engaging with the d/a tube, and will not hold the tube in place allowing the tube to move when actuated.Conclusion: based on the results of the investigation, it is determined that the non-conformance is a usage issue.The returned device shows evidence of tampering, post shipment.Possibly a result of improper refurbishment or other handling post delivery.No corrective action is necessary.
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