MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN ORTHOCORD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	228162
Medical Device Problem Codes	Crack (1135); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: investigation summary.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the deployer with the white sleeve cracked at the distal end.The red trigger was found in the inactive position.No other anomalies were noted.A functional test was performed to both plates.The red trigger was fully squeezed, the first plate was successfully deployed, no obstruction or difficulties while deploying were found.The red trigger was fully squeezed a second time, the second plate was successfully deployed, no obstruction or difficulties while deploying were found.It was verified that the pusher shaft tip is sliding out completely from the applier needle.The overall complaint was not confirmed as the observed condition of the truespan 24 degree plga would have not contributed to the complained device issue.Based on the investigation findings, the potential cause for the sleeve condition could be traced to failure to use a malleable graft retractor.As per the instructions for use (ifu): during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging soft tissue.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.As part of depuy synthes 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.
Event or Problem Description
It was reported that during a meniscal repair surgical procedure it was observed that the truespan 24 degree plga device did not work.During in-house engineering evaluation it was determined that the deployer with the white sleeve cracked at the distal end.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported; however, it was reported that the event occurred in 2026.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: TRUESPAN ORTHOCORD
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; 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: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25474143
• Report Number: 1221934-2026-02512
• Device Sequence Number: 10426286
• Product Code: MBI
• UDI-Device Identifier: 10886705026050
• UDI-Public: (01)10886705026050(10)10CQ5C(17)281130
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Catalogue Number: 228162
• Device Lot Number: 10CQ5C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown