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	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) 2026.Awaiting further information regarding the circumstances of the incident.Visual inspection of the defect: both ends of the pins are bent but intact.No fragments remain in the patient.It appears that the report concerns the peek anchor: this implant reportedly remained in the patient without being attached.Investigation is ongoing.
Event or Problem Description
(b)(4).Incident occured in france.Complaint description: observation in 1 photo: deformed needle tips - message: "sharp tip not removed".

• 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: 25030342
• Report Number: 3004549189-2026-00008
• Device Sequence Number: 15984222
• Product Code: GAT
• UDI-Device Identifier: 03760304680526
• UDI-Public: 3760304680526
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K223122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: 260485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown