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

Model Number 228152

Device Problem Unintended Movement (3026)

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

Event Date 10/08/2022

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.Udi: (b)(4).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.

Event Description

This is report 2 of 2 for (b)(4).It was reported by a healthcare professional in china that during a meniscal repair procedure on (b)(6) 2022, it was observed that the truespan meniscal repair system peek 24 degree device could not fix the meniscus after deployment.Changed to another one to continue the surgery but the same problem happened again.Another like device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.No additional information could be 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.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.Investigation summary: the device was received and evaluated.When performing the visual inspection, the covering sleeve was removed to verify the presence of the plates, however, they were not returned.The applier needle has no structural anomalies that can interfere with a good deployment.The trigger was tested several times, it performed as intended, the spring pusher has no structural anomalies.A manufacturing record evaluation was performed for the finished device 9l25014 number, 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 inspection and the functional test results, this complaint cannot be confirmed.Since the device passed all visual and functional tests, and considering that both plates were not returned, we can conclude that the device has no issue.A possible root cause for the reported issue can be attributed to procedural variables, such handling of the device or product interaction during procedure.The depth penetration of the tissue was not maintained, therefore, the plate did not fully trespass the soft tissue and it was pulled out along with the device.As per ifu: fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first implant.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 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: 15657981
• MDR Text Key: 302504340
• Report Number: 1221934-2022-03234
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 228152
• Device Catalogue Number: 228152
• Device Lot Number: 9L25014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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