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

Model Number 228161

Device Problem Unintended Movement (3026)

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

Event Date 09/21/2022

Event Type  malfunction  

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 12 degree device would rotate in 360 degrees when it was taken out of the package.According to the report, the normal needle should be in a fixed position.It was further reported that the product was unusable.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.Udi: (b)(4).Reporter is a j&j employee.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.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
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> the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, the device was received without its packaging, the implants and suture were in the needle.The needle was deformed almost to break off from the shaft, mechanical damage and wear marks were found near the broken area.A manufacturing record evaluation was performed for the finished device lot number: 9l25630 and no nonconformances were identified.This complaint can be confirmed.During the manufacturing process, the truespan have two phases where the deployment gun is checked (the step of load implant onto needle, third step of load 3-hole implant onto needle and the implant system routing check), this test guaranties the applier has been properly assembled and functional.This information corresponds to a process control and there are 100% inspection in station 3, and it is the appropriate document to use to guarantee that this issue can¿t have happened during manufacturing process.A manufacturing investigation was performed, it is not possible to assemble with a rotation: to assemble a gauge is used: position the pushrod, needle/slider assembly in the vertical slot with the tip of the slider facing outwards and place the needle in the groove of the corner pad.Slide the slider pin into place to hold the assembly together.The needle must fit into the groove of the corner block.The pin locks the needle in place.If this is not the case, we cannot assemble.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.Complaint research, with the same defect did show 0 other case with this issue from 2019 to now with the item reference 228161: no nr was found during the research.The root cause is not manufacturing related.The possible root cause can be related to variables, such handling of the device or product interaction before procedure causing stress and a mechanical deformation which can caused to breaking.However, it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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.

• 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: 15546170
• MDR Text Key: 301591475
• Report Number: 1221934-2022-03044
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026043
• UDI-Public: 10886705026043
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• 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: 9L25630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• 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