MAUDE Adverse Event Report: S.B.M. SAS ComposiTCP Suture Anchors; ComposiTCP Double Loaded BroadBand Suture Anchor

Model Number	110026109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); Unspecified Musculoskeletal problem (4535)
Type of Reportable Event	Serious Injury
Event or Problem Description
Mfr report #: 3004549189-2026-00007.(b)(6) is the us initial importer for s.B.M.Sas.Manufacturer file(b)(4).Incident occurred in france.Complaint description: malunion of the cuff tear fixation, reoperation (b)(6)2025.The device was a compositcp 5.5 mm double loaded broadband suture anchor, ref.(b)(4), lot 243434, implanted on (b)(6)2024 at clinique mutualiste de bretagne, quimper.Malunion of the rotator cuff tear fixation occurred and a reoperation was performed on (b)(6)2025, which included removal of the devices and a new rotator cuff repair.The device is not available for evaluation.The complaint was reported to the manufacturer as part of an ongoing retrospective clinical study by its distributor.Manufacturer investigation: lot 243434 (assembly of 50 devices) had no rejects and no incidents during manufacturing and meets specifications.The surgeon indicated that the event was unrelated to the device: the patient had sleeve surgery prior to the shoulder surgery, which induced nutritional deficiency and impacted the healing process.The manufacturer concluded the issue is not related to the quality of the devices, notes the risk of postoperative re-tear is identified in its risk assessment, and has closed the complaint file.(b)(6) first received this event from the manufacturer on 16-sep-2026 as the manufacturer's follow-up #1 (additional information) dated (b)(6)2026; manufacturer related report number (b)(4).

• Brand Name: ComposiTCP Suture Anchors
• Common Device Name: ComposiTCP Double Loaded BroadBand Suture Anchor
• Manufacturer (Section D): S.B.M. SAS; zi du monge; lourdes 65100 ; FR 65100
• MDR Report Key: 50785629
• Report Number: 3012602431-2026-00091
• Device Sequence Number: 9525156
• Product Code: MAI
• UDI-Device Identifier: 03760154008259
• UDI-Public: 03760154008259
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025
• Report Date (Section F): 05/27/2025

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 Model Number: 110026109
• Device Lot Number: 243434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/16/2026
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/16/2026