MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 0 DEGREE PLGA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	228160
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the truespan 0 degree plga device was already outside of the needle when taking it from the package.During an in house engineering evaluation it was found that the device fell apart.This event did not occur during surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2025.All available information has been disclosed.
Additional 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.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 j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device comes out of its original package.The device comes in used condition.Biological matter can be observed on the spring pusher.Both plates are already deployed.No other anomalies were found.As per the information provided with the complaint the suture is visibly outside and the implants are activated, additionally, the extension spring had stains that could indicate that possibly the device was manipulated after the device was manufactured.Root cause description and rationale: the investigation performed showed that the production controls implemented at the non-sterile level, as well as the in-process controls guarantee detection of issues related to premature off- loading of the implant.The overall complaint was confirmed as the observed condition of the truespan 0 degree plga would have contributed to the complained device issue.Based on the findings, the out of the box issue is not confirmed due to the evidence of use.A potential cause for the deployed plates is traced to procedural variables, such handling of the device or product interaction during procedure: the plates may was deployed unintendedly by the user; however, this cannot be conclusively determined.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.Device history lot: there were no non-conformances related to this event.

• Brand Name: TRUESPAN 0 DEGREE PLGA
• Common Device Name: 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: 21980142
• Report Number: 1221934-2025-01677
• Device Sequence Number: 8908462
• Product Code: MBI
• UDI-Device Identifier: 10886705026036
• UDI-Public: (01)10886705026036(10)9L78395(17)251031
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K153667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 228160
• Device Lot Number: 9L78395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown