Model Number 228143 |
Device Problem
Device-Device Incompatibility (2919)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/25/2021 |
Event Type
malfunction
|
Event Description
|
It was reported by the sales rep in (b)(6) that during an anterior cruciate ligament reconstruction surgery on (b)(6) 2021, it was observed that the meniscal deployment gun device had a hard trip and was stiff; and that it did not shoot the needle.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
|
|
Manufacturer Narrative
|
The lot number was unknown; therefore, the manufacturing site name was unknown.Udi: (b)(4).The lot number was unknown.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.
|
|
Manufacturer Narrative
|
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.B5: upon follow up with the reporter it was determined that there was a 1015 minute delay in the procedure.D4: no lot number was provided in the initial report and has been updated accordingly.Udi: (b)(4).
|
|
Manufacturer Narrative
|
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: d4, h4: the expiration and device manufacture dates were reported as unknown on the initial report; and have been updated accordingly.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
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: investigation summary = > the complaint device was received and evaluated; by reviewing the physical device, it has no external anomalies, however, when reviewing the deployment slider, it could be observed that shows a small amount of biological matter and it is not bent.The loading rod which is controlled with the red trigger is in good condition, no structural anomalies were found.When performing the functional test, there were no obstructions while the triggers were activated.The removable needle was not returned along with its sutures.A manufacturing record evaluation was performed for the finished device 8l17160 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, and the functional test results, this complaint cannot be confirmed.Since the triggers have no failure and the condition of the deployment slider and loading rod are in good structural condition, we can conclude that the device has no issue.The needle used in this particular procedure was not returned, and is needed for providing a root cause for the plate deployment failure.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
|
|
Search Alerts/Recalls
|
|