ComposiTCPRecalls & reported problems across all models
S.B.M · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 1
We found 6 models of ComposiTCP by S.B.M in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between May 5, 2021 and Sep 20, 2026 — classified as 6 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ComposiTCP recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 7, 2021Completed
Mislabeled product.
Z-1361-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported ComposiTCP problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Fracture3
- Break1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient3
- Insufficient Information2
- Rupture2
- Unspecified Musculoskeletal problem2
- Muscle/Tendon Damage1
- No Clinical Signs, Symptoms or Conditions1
ComposiTCP models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ComposiTCP ComposiTCP 30 round headFastener, Fixation, Biodegradable, Soft Tissue1 recall0 reports
- ComposiTCP™ Double loaded BroadBand suture anchorFastener, Fixation, Biodegradable, Soft Tissue3 reports
- ComposiTCP™ Double loaded BroadBand suture anchorFastener, Fixation, Biodegradable, Soft Tissue2 reports
- ComposiTCP ComposiTCP 60 round headFastener, Fixation, Biodegradable, Soft Tissue1 report
- ComposiTCP ComposiTCP 60 flat headFastener, Fixation, Biodegradable, Soft Tissue1 report
- ComposiTCP ComposiTCP 30 round headFastener, Fixation, Biodegradable, Soft Tissue1 report
Recent ComposiTCP adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Muscle/Tendon Damage
MAUDE report 50833705 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
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
Patient problems: Rupture; Unspecified Musculoskeletal problem
MAUDE report 50785629 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
(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.
Patient problems: Insufficient Information; Rupture; Unspecified Musculoskeletal problem
MAUDE report 24964481 ↗InjuryMay 1, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPLANTING THE IMPLANT, THE IMPLANT FRACTURED. THE SURGEON WAS ABLE TO REMOVE THE PROXIMAL PORTION OF THE IMPLANT, BUT THE DISTAL PORTION WAS WELL FIXED IN THE PATIENT'S BONE. THE SURGEON DECIDED TO LEAVE THE PORTION REMAINING IN THE PATIENT'S BONE. THERE IS NO PLAN TO REVISE THE PATIENT TO REMOVE THE FOREIGN BODY AT THIS TIME. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 21942655 ↗MalfunctionApr 7, 2025Break; Break
(B)(4). INCIDENT OCCURED IN GERMANY. COMPLAINT DESCRIPTION: "THE TIP OF THE SCREW BROKE OFF WHEN IT WAS INSERTED INTO THE DRILLING CHANNEL. ALL PARTS WERE REMOVED FROM THE PATIENT". NO IMPACT TO PATIENT - 55-MINUTE DELAY STIPULATED IN EXPERIENCE REPORT RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21784862 ↗InjuryMar 28, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE SCREW FRACTURED WHILE PERFORMING IMPLANTATION. PIECES OF THE SCREW REMAINS IN THE PATIENT'S BONE TUNNEL. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO OTHER COMPLICATIONS OR IMPACTS WERE REPORTED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 21724512 ↗InjuryOct 4, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL HAMSTRING TENDON GRAFT PROCEDURE, TWO INTERFERENCE SCREWS FRACTURED. HALF OF ONE SCREW REMAINS IN THE PATIENT'S BONE TUNNEL AND IS INDICATED TO BE STABLE WITHOUT THE POTENTIAL FOR MIGRATION. THE SURGEON STATED THAT REMOVING IT WAS NOT POSSIBLE, AND THE CASE WAS COMPLETED WITH A BONE POST OUTSIDE THE TUNNEL FOR GRAFT FIXATION. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO OTHER COMPLICATIONS OR IMPACTS WERE REPORTED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 20370650 ↗MalfunctionMay 5, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
FNC 2104/02183, EVENT OCCURED IN ENGLEWOOD / USA. COMPLAINT DESCRIPTION: BOTH SUTURES BROKE OFF IMPLANT ONCE ITEM WAS INSERTED INTO PATIENT'S TALUS. ITEM NAME: COMPOSITCP 4.5MM TWO #2 BBAND, ITEM NUMBER: 110026108, LOT NUMBER: 183502.
Patient problems: Insufficient Information
MAUDE report 11775810 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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