MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 228152

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

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

Event Date 06/05/2023

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.H10 additional narrative: udi: (b)(4).D4: the expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.Investigation summary: both a photo and the complaint device were received for evaluation.A photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual inspection of the photo revealed that the needle was broken.It could not be observed the implants and suture in the needle.The device was not in its original the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observation revealed that the needle was deformed and broken from the shaft.The implants and suture were not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number: 9l62966, and no nonconformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.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 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.The possible root cause for the needle damage can be attributed when the needle was inside the joint and the needle tip was maneuver to desired location for optimal approximation, it was leveraged, therefore causing stress and a mechanical deformation which can caused to breaking.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, during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging tissue.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

It was reported by a healthcare professional in china that during an unknown procedure on an unknown date, it was observed that the needle on the truespan meniscal repair system peek 24 degree device was detached upon opening its package; and therefore, was not used.During in-house engineering evaluation, it was determined that visual observation revealed that the needle was deformed and broken from the shaft.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 PEEK 24 DEGREE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• 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: 17397132
• MDR Text Key: 320375577
• Report Number: 1221934-2023-02788
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026029
• UDI-Public: 10886705026029
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228152
• Device Lot Number: 9L62966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• 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