MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN MENISCAL REPAIR SYSTEM PLGA 24 DEGREE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228162

Device Problem Device-Device Incompatibility (2919)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/24/2022

Event Type  Injury  

Event Description

This is report 2 of 3 for (b)(4).It was reported by the customer in switzerland that during a meniscal repair procedure on (b)(6) 2022, it was observed that the deployment on the truespan meniscal repair system plga 12 degree device did not work.According to the report, the surgeon had to take another truespan meniscal repair system plga 12 degree which did not work either.It was further reported that after two 12° truespan failed, a 24° truespan was used, which did not work either.It was reported that because the meniscus was already damaged, the surgeon had to take out a part of the meniscus (5 mm x 10 mm) and then switched to another product.It was unknown if the procedure was completed.The status of the patient was unknown.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.Udi: (b)(4).The expiration date is currently unavailable.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.

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: d4, h4: the expiration date and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.Therefore, udi: (b)(4).Investigation summary: the three products reported were returned to mitek for evaluation without lot identification.Mitek then conducted visual inspection of devices received.The device was received and evaluated.Visual inspection revealed that the implants and suture were not received along with the device.There are no anomalies or structural damage on the outside of the device and pusher rod.To test its functionality, the red trigger was tested and after actioned, no anomalies were found.A manufacturing record evaluation was performed for the finished device lot number: 9l11321, and no nonconformances were identified.According with the visual inspection and functional test, this complaint cannot be confirmed.Based on the meniscal repair technique guide, it is necessary to choose the portal which most easily allows the delivery needle to be inserted perpendicular to the tear site.Also, the possible root cause for the deployment failure could be related when not inserting the needle to the proper depth for deployment which have caused blocking insertion of the first implant, and when this occurred may have felt resistance and did not pull the trigger all the way.However, it cannot be conclusively affirmed.As per ifu, it is important that the device is positioned correctly.Also, it is necessary to use a calibrated probe, measure the width of the meniscal tissue to be repaired and set the adjustable depth.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: TRUESPAN MENISCAL REPAIR SYSTEM PLGA 24 DEGREE
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14986715
• MDR Text Key: 295689466
• Report Number: 1221934-2022-02089
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026050
• UDI-Public: 10886705026050
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228162
• Device Catalogue Number: 228162
• Device Lot Number: 9L11321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention