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

Catalog Number	223751
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
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 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 (10ccml), 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 a patient experienced septic infection after acl (ant.Cruciate ligament) reconstruction surgery where j&j implants (dynacord x1, speedtrap x4, milagro x1, rigidloop x1, absolute x1) were utilized.The initial acl case took place on (b)(6), 2026.During the case, there was no notable incident observed, all procedures followed hospital policy and the case duration was approximately 1.5 hours.After surgery, patient visited the surgeon for consultation and surgeon prescribed antibiotics and cleaned wound.As situation was not improved, a second surgery was arranged on (b)(6), 2026 to remove all implants and washed the joint with antibiotics.All implants were discarded on (b)(6), 2026.All available information has been disclosed.Report 8 of 8 for (b)(4).

• 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 02400 ; SZ 02400
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25796236
• Report Number: 1221934-2026-03031
• Device Sequence Number: 9054128
• Product Code: GAT
• UDI-Device Identifier: 10886705027972
• UDI-Public: (01)10886705027972(10)10CCML(17)301031
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 223751
• Device Lot Number: 10CCML
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown