MAUDE Adverse Event Report: S.B.M. SAS MENISCAL SUTURE SYSTEM; MENIX® DUO MENISCAL SUTURE SYSTEM WITH TWO ANCHORS

Catalog Number	MEN0201901
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Rupture (2208); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6), 2025.Event description: "the peek implants did not deploy properly.In the first case, the repair appeared to be well fixed; however, when tying the knot, the suture broke.A second device was used, but the implants failed to properly deploy behind the capsule.A third device was then used, and the same issue occurred.A total of three devices were involved: two units from batch 254186 and one unit from batch 254178.All three issues occurred during the same surgery.The surgery duration was approximately 40 minutes.The physician considered it a difficult case to repair.The joint was defined as challenging due to the limited working space and the complexity of the lesion.As the meniscal repair could not be successfully completed using sutures, the procedure was finalized with a partial meniscectomy".Verification of manufacturing data: the batches concerned comply with the expected specifications.Insufficient information: date and location of the incident not provided; patient impact unknown.Devices are not available for expertise - incident report to be completed and sent.Request for additional information to complete our investigation: first device: can you describe the exact circumstances (the repair appeared to be well fixed; however, when tying the knot, the suture broke)? could you explain? once the device was placed in the tissue, was there a feeling of difficulty or of restraint when the sutures were pulled? what is the approximate length of the remaining suture in the surgeon's hand after rupture? second and third devices / "the implants failed to properly deploy behind the capsule": what happened? what difficulties did you encounter? could you tell us what shape the lesion was? which area of the meniscus was operated on? what was the condition of the patient's meniscus before the procedure? what percentage of the intervention area was viable? do you have any photos of the faulty devices?.
Event or Problem Description
(b)(4) incident occured in argentina.Complaint description: event description: "the peek implants did not deploy properly.In the first case, the repair appeared to be well fixed; however, when tying the knot, the suture broke.A second device was used, but the implants failed to properly deploy behind the capsule.A third device was then used, and the same issue occurred.A total of three devices were involved: two units from batch 254186 and one unit from batch 254178.All three issues occurred during the same surgery.The surgery duration was approximately 40 minutes.The physician considered it a difficult case to repair.The joint was defined as challenging due to the limited working space and the complexity of the lesion.As the meniscal repair could not be successfully completed using sutures, the procedure was finalized with a partial meniscectomy".

• Brand Name: MENISCAL SUTURE SYSTEM
• Common Device Name: MENIX® DUO MENISCAL SUTURE SYSTEM WITH TWO ANCHORS
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes, 65100 ; FR 65100
• Manufacturer (Section G): S.B.M. SAS; zi du monge; lourdes, 65100 ; FR 65100
• Manufacturer Contact: regine estaun ; zi du monge; lourdes, 65100 ; FR 65100
• MDR Report Key: 24556006
• Report Number: 3004549189-2026-00006
• Device Sequence Number: 9440723
• Product Code: GAT
• UDI-Device Identifier: 03760304680526
• UDI-Public: 3760304680526
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K223122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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: MEN0201901
• Device Lot Number: 254186 ; 254178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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: Other
• Patient Sex: Unknown