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

Catalog 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); Insufficient Information (4580)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4).Incident occured in france.Complaint description: "malunion of the cuff tear fixation reoperation (b)(6) 2025".Product: unknown compositcp suture anchor double loaded with broadband tape (sliding) - no item/lot identification provided country of event: france date of implant: (b)(6) 2024.Date of event: (b)(6) 2025.Malunion of the cuff tear fixation; reoperation performed postoperatively.No additional information is available.
Additional Manufacturer Narrative
As of (b)(6) 2026, there is not enough information about the implanted device: it is not possible to verify the manufacturing data.To complete our investigation, additional information was requested: 1.Was the first surgery, which took place on (b)(6) 2024, performed at the same facility? 2.What was the batch number of the device used? 3.According to a surgeon's opinion, what could be the potential cause of this rotator cuff tear? 4.The reoperation took place on (b)(6) 2025, and the incident was reported in (b)(6) 2026: what caused this delay in reporting? 5.What did the follow-up procedure involve? removal of the device? a new repair? 6.November 2024: bone quality for insertion zone? (dense, medium, weak).7.Could the incident (rotator cuff rupture) be related to a malfunction of the device? 8.Are there any x-rays, mris, or photos available? 9.Did the health care facility declare this incident to the national competent authority? 10.If so, what is the ansm file number? device not available.____________________________________________________.
Event or Problem Description
(b)(4) incident occurred in france.Complaint description: "malunion of the cuff tear fixation reoperation (b)(6)2025".Product: unknown compositcp suture anchor double loaded with broadband tape (sliding) no item/lot identification provided, country of event: france, date of implant: (b)(6)2024, date of event: 27-may-2025, malunion of the cuff tear fixation; reoperation performed postoperatively.No additional information is available.
Additional Manufacturer Narrative
April 23, 2026 there is not enough information about the implanted device: it is not possible to verify the manufacturing data.To complete our investigation, additional information was requested: 1.Was the first surgery, which took place on (b)(6) 2024, performed at the same facility? 2.What was the batch number of the device used? 3.According to a surgeon's opinion, what could be the potential cause of this rotator cuff tear? 4.The reoperation took place on (b)(6) 2025, and the incident was reported in march 2026: what caused this delay in reporting? 5.What did the follow-up procedure involve? removal of the device? a new repair? 6.(b)(6) 2024: bone quality for insertion zone? (dense, medium, weak) 7.Could the incident (rotator cuff rupture) be related to a malfunction of the device? 8.Are there any x-rays, mris, or photos available? 9.Did the health care facility declare this incident to the national competent authority? 10.If so, what is the ansm file number? device not available.September 08, 2026 additional information follow up1.Concerning the products: devices rejected during the re intervention.Ref.(b)(4) - compositcp ø 5.5 mm double loaded broadband suture anchor - lot 243434.Assembly of (b)(4) devices - no rejects - no incidents during manufacturing.The batch meets the expected specifications.Manufacturing date: 2024-09-02.Expiration date: 2027-09-01.Result of analysis: malunion of the cuff tear fixation: reoperation performed postoperatively.This complaint was reported as part of an ongoing retrospective clinical study by our distributor.Cause of the failure: the surgeon indicated that "the event was unrelated to the device.Patient had a sleeve surgery prior to the shoulder surgery, wich induced nutritional deficiency and impacted his healing process"."revision surgery included removal of the devices, and a new rotator cuff repair." the sleeve surgery caused nutritional deficiencies that affected tissue healing: this issue is not related to the quality of the devices used.This risk of postoperative rupture is identified in our risk assessment document rmr 2019.03 - risk cr-19 re-tear of the rotator cuff.In this incident, the gastric sleeve was identified as a factor that may influence tissue healing following rotator cuff repair.This factor will be taken into account to assess its potential impact on clinical outcomes.The relevant documents will be updated accordingly.This complaint file is closed.

• 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
• 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: 24964481
• Report Number: 3004549189-2026-00007
• Device Sequence Number: 17381973
• Product Code: MAI
• UDI-Device Identifier: 03760154008259
• UDI-Public: 03760154008259
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 110026109
• Device Lot Number: 243434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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