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

Model Number 228162

Device Problems Break (1069); Device Damaged Prior to Use (2284); Material Deformation (2976)

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

Event Date 12/08/2022

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.Additional narrative: udi: (b)(4).Reporter is a j&j employee.The device manufacture date is currently unavailable.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.The device was not received in its entire original packaging.Upon visual inspection, the observation revealed that the needle was broken off from the shaft.Mechanical deformation showed near the broken area.The implants were received along with the shaft, they appeared to be deployed.The trigger was tested, and it worked as intended.A manufacturing record evaluation was performed for the finished device lot number: 9l60695, and no nonconformances were identified.This complaint can be confirmed and a root cause for the issue experienced cannot be determined.Based on the damage near the broken area, the possible root cause can be attributed when the needle tip was maneuver and it was leveraged, therefore causing stress and a mechanical deformation which can caused to breaking; moreover, handling variables of the device or product interaction before procedure.The process of the truespan have two phases where the deployment gun is checked (the step of applier functional testing, packaging, and the implant system routing check), this test guaranties the gun has been properly assembled and is functional.This information corresponds to a process control, and it is the appropriate document to use to guarantee that this issue can¿t have happened during manufacturing process.No information was provided on how this failure has occurred or specifications of the procedure, therefore a definitive root cause could not be determined.However, it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.A further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of 100 devices that were released to distribution.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.

Event Description

It was reported by the affiliate in japan that during a meniscal repair procedure on (b)(6) 2022, it was observed that the needle on the truespan meniscal repair system plga 24 degree was already broken upon opening its package and before use.During in-house engineering evaluation, it was determined that the needle was broken off from the shaft on the device.It was further determined that mechanical deformation showed near the broken area.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.

• 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: 16437821
• MDR Text Key: 310291444
• Report Number: 1221934-2023-00881
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026050
• UDI-Public: 10886705026050
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228162
• Device Catalogue Number: 228162
• Device Lot Number: 9L60695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Initial Date Manufacturer Received: 02/05/2023
• Initial Date FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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