MEDOS INTERNATIONAL SARL TRUESPAN MENISCAL REPAIR SYSTEM PLGA 12 DEGREE; SOFT-TISSUE ANCHOR, BIOABSORBABLE
|
Back to Search Results |
|
Model Number 228161 |
Device Problems
Break (1069); Migration (4003)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/02/2022 |
Event Type
malfunction
|
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 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 is a j&j sales representative.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.
|
|
Event Description
|
It was reported by the sales rep in hong kong that during an unknown surgery on (b)(6) 2022, it was observed that the truespan meniscal repair system plga 12 degree device pulled out after the 2nd firing; and its suture was torn.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
|
|
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 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.H10 additional narrative: 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 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.H10 additional narrative: investigation summary: the device was received and evaluated.The two plates were returned.Upon visual inspection of the needle, the silicone sleeve that holds the implants have no anomalies.The two plates were reviewed, no anomalies were found.The suture of the second plate is broken.The red trigger was tested several times and it worked as intended.The spring pusher tip is not damaged.A manufacturing record evaluation was performed for the finished device 9l19472 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 and testing result, this complaint can be confirmed.The possible root cause for the reported issue can be attributed to procedural variables, such handling of the device or product interaction during procedure.An excessive force was applied to the suture when it was tightened, therefore, the second plate was forced through the soft tissue and it was pulled out and its suture broke, however, this cannot be conclusively determined.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
|
|
|