MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 12 DEGREE PEEK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 228151

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported by the sales rep that during a meniscal repair surgery on (b)(6) 2024, 3 x truespan 12 degree peek devices misfired.It was reported that two of the devices did not deploy at all, made a loud click and the implants did not advance and one device did deploy but the suture broke when tensioning.Another three like devices of a different lot number were used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.Report 2 of 3 for (b)(4).

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.Device was used for treatment, not diagnosis.H10 additional narrative: (b)(4) h4: 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 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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

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.H10 additional narrative: the investigation has been updated to reflect the correct information: investigation summary according to the information received, it was reported i had 3 of the same lot # misfire today.We used 3 of a different lot # and they worked to complete the repair.Lot# 239l426 did not work.Meniscal repair.No patient consequences.Two did not deploy at all and made a loud click and the implants did not advance.One did deploy, but the suture broke when tensioning.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of the device received.The complaint device was received and evaluated; visual inspection reveals that the red trigger is broken.The plates and the suture were found still attached to the needle.The device was opened to verify the broken part, it was found that the upper part of the red trigger was broken.The applier needle was found in a normal condition a functional test was unable to be performed due to the condition of the device.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the truespan 12 degree peek would contribute to the complained device issue.¿ based on the investigation findings, the potential cause could be traced to a portion of tissue that was entered inside the applier needle causing a mechanical obstruction of the first plate when it was going to be deployed; this obstruction and the force applied to the trigger are contributive factors of the broken trigger.Therefore, it has been determined that no corrective and/or preventative action is required.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Correction h4: the device manufacture date was reported as unknown on the initial report.Please note that the date of manufacture has been updated accordingly.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• 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 ; 3035526892
• MDR Report Key: 18730468
• MDR Text Key: 336403426
• Report Number: 1221934-2024-00492
• Device Sequence Number: 1
• Product Code: MBI
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228151
• Device Lot Number: 239L426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 03/15/2024
• Supplement Dates FDA Received: 03/13/2024; 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2023
• 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