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

Model Number 228152

Device Problems Break (1069); Device-Device Incompatibility (2919)

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

Event Date 12/07/2022

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.Additional narrative: udi: (b)(4).The expiration 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.

Event Description

It was reported by a healthcare professional in china that during a meniscal repair procedure on (b)(6) 2022, it was observed that the suture on the truespan meniscal repair system peek 24 degree device broke when tightened.Another like device was used to complete the surgery.There were no adverse consequences to the patient.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 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.Investigation summary: the actual device has been returned and is currently pending evaluation.However, a photo was provided.Upon visual inspection of the photo, the two implants were deployed.The suture appeared to be slightly damage near the implant.The complaint reported was confirmed.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.The possible root cause can be attributed to a sharp instrument rubbed the suture and an excessive force applied to the suture now of tightening the repair.A manufacturing record evaluation was performed for the finished device lot number: 9l74272, and no nonconformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Please note that once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Correction h4: it was documented in the initial medwatch report that the date of manufacture (dom) was unknown.The dom has been received and corrected to 26 aug 2022.

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 both plates were already deployed, the plastic sleeve was removed to verify the integrity of the applier needle, the applier needle is in good shape, no structural anomalies could be found.The suture was in good conditions, it does not show any structural damage.The red trigger was tested several times, it worked as intended.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.Due to the condition of the plates this complaint can be confirmed.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an excessive manipulation of the device, tilting and twisting movements of the device while it was inserted causing the first plate to be slipped out of the plate container; therefore, the two plates were released at the same time, however this cannot be conclusively determined.The suture is in good condition no anomalies could be found.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: 16070047
• MDR Text Key: 308477332
• Report Number: 1221934-2022-04319
• Device Sequence Number: 1
• Product Code: MBI
• 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: 12/29/2022
• 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: 9L74272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• 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