MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN MENISCAL REPAIR SYSTEM PLGA 12 DEGREE; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228161

Device Problems Material Twisted/Bent (2981); Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

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).Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received provided by customer.Visual inspection reveals wear by use in the device.It was identified that the two implants with the suture were still attached partially deployed in the needle.Also, it could be observed the needle was found bent.Finally, the red trigger was reviewed and tested, it performed as intended.The pusher rod that places the implants is also in good shape, no structural anomalies could be found.A manufacturing record evaluation was performed for the finished device lot number: 8l92327, and no nonconformances were identified.According with the visual inspection result, this complaint can be confirmed.The possible root cause for the condition of the device could be related to excessive manipulation; moreover, mishandling, procedural variables or product interaction during procedure could cause the bent condition of the needle.However, it cannot be conclusively affirmed.As per ifu-113244, for the needle insertion, it is necessary use a calibrated probe, measure the width of the meniscal tissue to help insert into the joint.Set the adjustable depth stop to minimize tissue penetration 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.

Event Description

It was reported by the sales rep that during a meniscal repair procedure on (b)(6) 2022, it was observed that the needle on the truespan meniscal repair system plga 12 degree device was bent down instead of up.According to the report, it was noticed after putting the device into the joint.During in-house engineering evaluation, it was determined that the needle on the device was bent.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: TRUESPAN MENISCAL REPAIR SYSTEM PLGA 12 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: 14856646
• MDR Text Key: 303151802
• Report Number: 1221934-2022-01923
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026043
• UDI-Public: 10886705026043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228161
• Device Catalogue Number: 228161
• Device Lot Number: 8L92327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2022
• 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