Arthrex® AR-1934BCF-2Recalls & reported problems
Arthrex, Inc. · SUTR ANCH,BIO-COMP S-TAK · Class 2 · Implant
Quick summary
This Arthrex Bio-Comp S-TAK suture anchor appears in 89 adverse event reports, with no deaths and 6 injuries. Reports mostly describe the anchor breaking, and anchors coming loose or moving out of place. Some patient problems listed include foreign bodies and infection. No recalls name this device.
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
- 92
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00888867023888), received between Nov 23, 2016 and Sep 22, 2026 — classified as 6 injuries, 86 malfunctions.
The most frequently reported specific device problem is “Break” (74 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break74
- Device Dislodged or Dislocated10
- Adverse Event Without Identified Device or Use Problem2
- Positioning Failure2
- Detachment of Device or Device Component1
- Failure to Advance1
- Fitting Problem1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions72
- Insufficient Information15
- Foreign Body In Patient4
- Hypersensitivity/Allergic reaction2
- Unspecified Infection2
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cyst(s)1
Recent adverse event reports
The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
On 9th September 2026, it was reported by an Arthrex's employee via an Email that 1 unit of AR-1934bcf-2, Suture Anchor, BioComposite¿ SutureTak® 3 x 14.5 mm, VE5 with #2 FiberWire® and #2 TigerWire®, was broken upon insertion into drilled tunnel. The drill used correctly and technique was good.This was detected during an unspecified procedure on (b)(6) 2026.Additional information received on 11th September 2026: This was detected during a Bankart with SLAP procedure on (b)(6) 2026. The procedure was completed successfully by using an AR-1934bcf-2. There was no patient harm. There wasn't any instrument or any implant breakage that was left inside patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854187 ↗MalfunctionSep 15, 2026Break
On 1st September 2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-1934BCF-2, Suture Anchor, BioComposite¿ SutureTak® 3 x 14.5 mm, VE5 with #2 FiberWire® and #2 TigerWire®, its anchor broke during insertion.This was detected during a labial repair surgery on (b)(6) 2026. The procedure was completed successfully by using another new AR-1934BCF-2. There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772643 ↗MalfunctionSep 15, 2026Break
On (b)(6)2026, it was reported by an Arthrex's employee via an Email that for 1 unit of AR-1934BCF-2, Suture Anchor, BioComposite¿ SutureTak® 3 x 14.5 mm, VE5 with #2 FiberWire® and #2 TigerWire®, its anchor broke during insertion.This was detected during a labial repair surgery on (b)(6) 2026. The procedure was completed successfully by using another new AR-1934BCF-2, There were no patient harm and no secondary procedure needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772367 ↗MalfunctionJul 31, 2026Break; Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099525 ↗MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099302 ↗MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098531 ↗MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50098014 ↗MalfunctionMar 30, 2026Break
ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANKLE JOINT INSTABILITY SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715232 ↗MalfunctionMar 30, 2026Break
ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANKLE JOINT INSTABILITY SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714120 ↗MalfunctionMar 30, 2026Break
ON 10TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN ANKLE JOINT INSTABILITY SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713871 ↗MalfunctionMar 30, 2026Positioning Failure
ON 11TH MARCH 2206, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWI RE® AND #2 TIGERWIRE®, AFTER THE ANCHOR WAS IMPLANTED INTO THE LABRUM, THE SURGEON TIED THE LABRUM UP AND THEN EXPLORED THE ACETABULUM. HE FOUND THAT SOME OF THE ANCHOR WAS EXPOSED INSIDE THE HIP, SO HAD TO EXTRACT THE ANCHOR AND INSERT ANOTHER ONE. THIS WAS DETECTED DURING A HIP ARTHROSCOPIC LABRAL REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW ANCHOR. BONE QUALITY OF PATIENT WAS NORMAL.THERE WAS NO PATIENT HARM AND NO SECONDARY SURGERY NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712814 ↗MalfunctionMar 26, 2026Break
ON 6TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 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-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698064 ↗MalfunctionMar 25, 2026Break
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A HIP JOINT LABRUM REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE DEVICE WAS CHANGED FOR A NEW ONE. AR-1949 AND AR-1250LT WERE USED TO PREPARE THE BONE SOCKET AND THE BONE QUALITY OF THE PATIENT WAS HARD. NO FRAGMENTS WERE LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 24686203 ↗MalfunctionFeb 25, 2026Break
ON 9TH FEB 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A PATELLAR DISLOCATION REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442035 ↗MalfunctionFeb 13, 2026Break
ON 27TH JAN 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A GLENOID LABRUM INJURY REPAIR SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24331568 ↗MalfunctionFeb 10, 2026Positioning Failure
ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWI RE® AND #2 TIGERWIRE®, ITS ANCHOR WAS NOT STABLE AFTER INSERTION. THIS WAS DETECTED DURING AN ANKLE JOINT REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24302976 ↗MalfunctionDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 1ST DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR WAS PULLED OUT WHEN RETRIEVING THE POLE. THIS WAS DETECTED DURING A REPAIR OF THE ANTERIOR CALCANEOFIBULAR LIGAMENT SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862700 ↗MalfunctionDec 22, 2025Break; Break
ON 1ST DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A HIP JOINT LABRUM REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862626 ↗MalfunctionDec 22, 2025Break; Break
ON 1ST DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, BOTH ITS ANCHORS BROKE DURING INSERTION. THIS WAS DETECTED DURING A HIP JOINT LABRUM REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE THIRD NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862555 ↗MalfunctionDec 22, 2025Break; Break
ON 1ST DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, BOTH ITS ANCHORS BROKE DURING INSERTION. THIS WAS DETECTED DURING A HIP JOINT LABRUM REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE THIRD NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862507 ↗MalfunctionDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR WAS PULLED OUT WHEN RETRIEVING THE POLE. THIS WAS DETECTED DURING A LABRAL SUTURING SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862376 ↗MalfunctionDec 22, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, THE END OF THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A LABRAL SUTURING SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23862318 ↗MalfunctionDec 18, 2025Break; Break
ON 28TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A CALCANEAL OSTEOTOMY SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23837138 ↗MalfunctionDec 8, 2025Break; Break
ON 11/17/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1934BCF-2 BIOCOMPOSITE¿ SUTURETAK ANCHOR WAS DAMAGED DURING INSERTION. THE BASE OF THE SUTURES BROKE, MAKING IT UNUSABLE. THIS WAS DISCOVERED DURING A BICEPS LESION PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. ADDITIONAL INFORMATION PROVIDED ON 11/26/2025: IT WAS FURTHER REPORTED THAT THE HOLE FOR THE ANCHOR WAS MADE USING A SUTURETAK ANCHOR DRILL AND THE DOCTOR USED THE MATERIAL CORRECTLY, THE PATIENT'S BONE WAS VERY HARD, WHICH CAUSED THE ANCHOR TO BREAK, NOT THE DRILL. THERE WERE NO LOOSE FRAGMENTS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23742056 ↗MalfunctionDec 4, 2025Break; Break
ON 17TH NOV 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1934BCF-2, SUTURE ANCHOR, BIOCOMPOSITE¿ SUTURETAK® 3 X 14.5 MM, VE5 WITH #2 FIBERWIRE® AND #2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A REPAIR OF THE DELTOID LIGAMENT SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1934BCF-2. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717447 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.