This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Initial reporter occupation: reporter is a j&j sales representative.The device manufacture date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
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It was reported by sales rep that during an unknown procedure on (b)(6) 2022, a mini qa+ w/ #2/0 ocord and v-5 needle w/bit device was used.It was reported that postoperatively on (b)(6) 2022, it was observed that the device was "eroding out of the patient¿s skin¿.According to the report, the patient received a procedure in clinic on (b)(6) 2022 where the physician assistant used a suture removal kit to cut out the protruding visible suture anchor material leaving a pinhole which she covered with ointment.It was reported that they did not get an imaging or use the c-arm in clinic.It was reported that the patient has a follow up appointment with their physician the following week but the exact date and time has not been confirmed yet.It was reported that the patient has ¿some redness around the dorsal 3rd of the phalanx.No additional information was provided.
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This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (8l67512), and no non-conformance was identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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