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

Model Number 228161

Device Problems Break (1069); Mechanical Problem (1384); Physical Resistance/Sticking (4012)

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

Event Date 09/16/2022

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).Reporter is a j&j sales representative.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.The observation revealed that both implants were still along with the needle and were not deployed.Also, it was observed that the trigger was loose and there was no tension on the handle, the gun was opened, and it was found that the initial part of the trigger was broken and disconnected from the firing spring, it indicates that the internal mechanism of the handle was not working.A manufacturing record evaluation was performed for the finished device lot number: 9l19471, and no nonconformances were identified.This complaint can be confirmed due to the implants were not deployed.This type of issue was previously reviewed with the manufacturer, based on the information received, the process of the truespan have two phases where the deployment gun is checked (the step of applier functional testing and the implant system routing check), this test guaranties the applier has been properly assembled and is functional.This information correspond 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.The possible root cause for the deploy failure reported could be related when not inserting the needle to the proper depth for deployment which have caused blocking insertion after deploying the first implant, and when attempt to fire the implant against the tissue, it can feel a resistance and excessive force could have caused stress on the handle thus causing the handle mechanism to break.However, it cannot be conclusively affirmed.As per ifu, 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.Also, at desired depth, squeeze the red deployment trigger while maintaining depth positioning to deliver the second implant.The implant is fully deployed when you hear an audible ¿click¿.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 an anterior cruciate ligament reconstruction procedure on (b)(6) 2022, it was observed that the trigger on the truespan meniscal repair system plga 12 degree device snatched when triggered.During in-house engineering evaluation, it was determined that the trigger was loose and there was no tension on the handle, the gun was opened, and it was found that the initial part of the trigger was broken and disconnected from the firing spring, it indicated that the internal mechanism of the handle was not working.Another like device was used to complete the procedure.No patient consequences or surgical delay reported.No additional information was provided.

• Brand Name: TRUESPAN MENISCAL REPAIR SYSTEM PLGA 12 DEGREE
• Type of Device: SOFT-TISSUE ANCHOR, NON-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: 15788594
• MDR Text Key: 307804411
• Report Number: 1221934-2022-03525
• 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: 11/14/2022
• 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: 9L19471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• 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