MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL SPEEDTRAP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	223751
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an unknown procedure, the speedtrap failed.After the graft was pulled into the joint and fixed femorally, the doctors wanted to knot the sutures of the tibial end of the graft, which were mounted by a speedtrap device, to the tibia through a suture washer.That's when they noticed that 1 thread of the speedtrap had broken.They had to make a small incision on the thigh to remove the rigidloop adjustable plate and then take the graft out through the joint.Then they resewed everything with a new rla and speedtrap device and fixed everything anew.Another device was used to complete the procedure.There was a 20 minute surgical delay in the procedure reported.There were no adverse patient consequences reported.All available information has been disclosed.
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 complaint device was discarded by the customer, therefore not returned to depuy synthes and unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (10cmdg), 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.Device history product number : 223751 lot number : 10cmdg there was no non-conformance regarding this lot.Manufacturing date: 12-dec-2025 expiration date: 30-nov-2030.

• Brand Name: SPEEDTRAP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• 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 CH-02 400; SZ CH-02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25425055
• Report Number: 1221934-2026-02428
• Device Sequence Number: 13291751
• Product Code: GAT
• UDI-Device Identifier: 10886705027972
• UDI-Public: (01)10886705027972(10)10CMDG(17)301130
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161638
• 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: Non-Healthcare Professional
• 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: 223751
• Device Lot Number: 10CMDG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown