Arthrex® AR-1927BCF-45Recalls & reported problems
Arthrex, Inc. · BIO-COMPSI CRKSCRW FT 4.5X 14MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex Bio-Composite Corkscrew anchor is an absorbable anchor used to reattach soft tissue to bone. Most reports describe the anchor breaking during insertion, some during rotator cuff repairs. The 156 reports include no deaths and 6 injuries. No recalls name this device, and reports fell from 59 in the prior 12 months to 33 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 164
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 00888867023376), received between Aug 9, 2016 and Sep 29, 2026 — classified as 7 injuries, 157 malfunctions.
The most frequently reported specific device problem is “Break” (158 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break158
- Patient Device Interaction Problem3
- Fitting Problem2
- Material Deformation2
- Detachment Of Device Component1
- Difficult to Insert1
- Difficult to Remove1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions144
- Insufficient Information9
- Foreign Body In Patient5
- Failure of Implant3
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Pain2
- Bacterial Infection1
Recent adverse event reports
The 25 most recent of 164 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933468 ↗MalfunctionSep 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933275 ↗MalfunctionSep 15, 2026Break
On 1st September 2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-1927BCF-45, 4.5 mm BioComposite-Corkscrew® FT Suture Anchor with one #2 FiberWire® and one TigerWire®, its anchor broke during insertion. This was detected during an arthroscopic rotator cuff repair surgery of the shoulder on (b)(6) 2026. The procedure was completed successfully by using another new AR-1927BCF-45. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774414 ↗MalfunctionSep 15, 2026Break
On 1st September 2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-1927BCF-45, 4.5 mm BioComposite-Corkscrew® FT Suture Anchor with one #2 FiberWire® and one TigerWire®, its anchor broke during insertion.This was detected during a rotator cuff repair surgery on (b)(6) 2026. The procedure was completed successfully by using another new AR-1927BCF-45. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772164 ↗MalfunctionSep 15, 2026Break
On 1st September 2026, it was reported by an Arthrex's employee via an Email that for 2 units of AR-1927BCF-45, 4.5 mm BioComposite-Corkscrew® FT Suture Anchor with one #2 FiberWire® and one TigerWire®, both its anchor broke off during insertion.The 1st anchor broke during insertion, and a 2nd AR-1927BCF-45 was changed to but the same issue happened again.This was detected during a rotator cuff repair surgery on (b)(6) 2026. The procedure was completed successfully by using another new AR-1927BCF-45. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771874 ↗MalfunctionSep 15, 2026Break
On 1st September 2026, it was reported by an Arthrex's employee via an Email that for 2 units of AR-1927BCF-45, 4.5 mm BioComposite-Corkscrew® FT Suture Anchor with one #2 FiberWire® and one TigerWire®, both its anchor broke off during insertion.The 1st anchor broke during insertion, and a 2nd AR-1927BCF-45 was changed to but the same issue happened again.This was detected during a rotator cuff repair surgery on (b)(6) 2026. The procedure was completed successfully by using another new AR-1927BCF-45. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771667 ↗MalfunctionSep 10, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50712640 ↗InjuryAug 10, 2026Patient Device Interaction Problem
Patient problems: Bacterial Infection; Pain; Purulent Discharge; Swelling/ Edema
MAUDE report 50191619 ↗MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098945 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50036093 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035040 ↗MalfunctionJul 27, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50008410 ↗MalfunctionApr 1, 2026Break
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, BOTH THE ANCHORS BROKE DURING INSERTION. THE 1ST AR-1927BCF-45 BROKE DURING INSERTION, AND ANOTHER AR-1927BCF-45 WAS CHANGED TO, BUT THE SAME ISSUE HAPPENED AGAIN. THIS WAS DETECTED DURING AN ARTHROSCOPIC SHOULDER SURGERY FOR ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A THIRD AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752801 ↗MalfunctionApr 1, 2026Break
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, BOTH THE ANCHORS BROKE DURING INSERTION. THE 1ST AR-1927BCF-45 BROKE DURING INSERTION, AND ANOTHER AR-1927BCF-45 WAS CHANGED TO, BUT THE SAME ISSUE HAPPENED AGAIN. THIS WAS DETECTED DURING AN ARTHROSCOPIC SHOULDER SURGERY FOR ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A THIRD AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24752643 ↗MalfunctionMar 26, 2026Break
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698178 ↗MalfunctionMar 26, 2026Break
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HAM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697983 ↗MalfunctionMar 26, 2026Break
ON 6TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697834 ↗MalfunctionMar 26, 2026Break
ON 6TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, IT'S ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697774 ↗MalfunctionMar 25, 2026Break
ON 5TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEW AR-1927BCF-45 WAS USED. AR-1922P AND AR-1927PTB-45 WERE USED TO PREPARE THE BONE SOCKET. THE BONE QUALITY OF PATIENT WAS HARD, AND NO FRAGMENTS WERE LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 24687653 ↗MalfunctionMar 25, 2026Break
ON 5TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEW AR-1927BCF-45 WAS USED. AR-1922P AND AR-1927PTB-45 WERE USED TO PREPARE THE BONE SOCKET. THE BONE QUALITY OF PATIENT WAS HARD, AND NO FRAGMENTS WERE LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 24686375 ↗MalfunctionMar 20, 2026Break
ON 2ND MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, BOTH ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF AND LABRUM INJURY SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649132 ↗MalfunctionMar 20, 2026Break
ON 2ND MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, BOTH ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF AND LABRUM INJURY SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649126 ↗MalfunctionMar 18, 2026Break
ON 27TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, THE HEAD END OF THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634004 ↗MalfunctionMar 18, 2026Break
ON 27TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A PATELLAR LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630598 ↗MalfunctionMar 18, 2026Break
ON 27TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927BCF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24627665 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page