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

Model Number 228151

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 11/23/2022

Event Type  malfunction  

Event Description

It was reported by the sales rep in chile that during a anterior cruciate ligament reconstruction procedure with meniscal repair on 11/23/2022, it was observed that the white protector detached from the gun without the possibility of firing the second peek implant on the truespan meniscal repair system peek 12 degree device.Another like device was used to complete the procedure with a delay of 10 minutes.There were no adverse patient consequences 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.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 mitek or its employees that the report constitutes an admission that the device, 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.The complaint device was received and evaluated; visual inspection reveals that the white sleeve is damage toward the distal part, the sleeve was placed in the correct position, the transparent silicone sleeve was found out the plate container.The needle is bent downwards.The suture and the plates were not returned.During the functional inspection, the red trigger was tested several times, it worked as intended.The tip of the spring pusher shaft was reviewed for bendings, no anomalies were found.A manufacturing record evaluation was performed for the finished device and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual and functional test result, this complaint cannot be confirmed for the non deploying issue since the plates and the suture were not returned for evaluation.The possible root cause for the damage in the sleeve can be attributed to procedural variables, such handling of the device or product interaction during procedure, the sleeve may was stuck in the knee internal walls therefore the sleeve was pulled out when removing the gun.The possible root cause for the deformed needle can be attributed to procedural variables, such handling of the device or product interaction during procedure; an excessive manipulation of the device, tilting movements of the applier needle while it was inserted causing the needle to be deformed, however, this cannot be conclusively determined.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.

• Brand Name: TRUESPAN MENISCAL REPAIR SYSTEM PEEK 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: 16001596
• MDR Text Key: 306285512
• Report Number: 1221934-2022-04026
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 9L38344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1