ComposiTCP™ Double loaded BroadBand suture anchor (REF 110026108)Recalls & reported problems
S.B.M · Threaded anchor system Ø 4.5 mm · Class 2 · Implant
All models of ComposiTCP (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03760154008242), received between May 5, 2021 and May 1, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗
Other Fastener, Fixation, Biodegradable, Soft Tissue devices
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- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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