MAUDE Adverse Event Report: Medos International SÃ rl TRUESPAN ORTHOCORD; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	228162
Medical Device Problem Codes	Device-Device Incompatibility (2919); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
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: the complaint device was implanted in patient, therefore not returned to depuy synthes and unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (10h13b), and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and 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 an anterior cruciate ligament/meniscus surgery, the surgeon stated the deployment of the truespan orthocord implants felt "different" than the normal.It did not click like normal with deployment - the device either made a faint noise to question if the implant deployed or made a loud clunk.The implants deployed even with the unusual sounds; however, the suture loops appeared to be wound together which made tensioning more difficult than normal.The surgeon expressed that he was not sure if he was able to fully tension the implants, or if the suture was bunched together, causing laxity in the repair.There was no patient or user harm reported.There was no significant delay in surgery.All available information has been disclosed.Report 2 of 3 for (b)(4).

• Brand Name: TRUESPAN ORTHOCORD
• 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 SÃ rl; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50717935
• Report Number: 1221934-2026-04070
• Device Sequence Number: 9853064
• Product Code: MBI
• UDI-Device Identifier: 10886705026050
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• 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: 10H13B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2026
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown