Arthrex® AR-1927BCT-475Recalls & reported problems
Arthrex, Inc. · CORKSCREW FT, BC, SUTURETAPE, 4.75MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex Corkscrew FT suture anchor, a biodegradable anchor used to secure tendons and ligaments to bone, appears in 30 adverse event reports with 1 injury and no deaths. Most reports describe the anchor cracking or breaking during surgery, sometimes leaving a fragment of the anchor or its inserter lodged in the bone that surgeons could not retrieve. 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
- 31
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00888867237858), received between Oct 19, 2021 and Sep 16, 2026 — classified as 1 injury, 30 malfunctions.
The most frequently reported specific device problem is “Break” (27 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break27
- Crack5
- Difficult to Remove2
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information14
- Foreign Body In Patient4
- Failure of Implant2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Break
Patient problems: Insufficient Information
MAUDE report 50789871 ↗MalfunctionFeb 3, 2026Break
ON 12-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT WAS USED WITH THE CORRECT PUNCH AND TAP DUE TO HARD BONE QUALITY. THE SURGEON INSERTED THE CORKSCREW APPROPRIATELY, AND AS THE ANCHOR WAS NEARLY FLUSH WITH THE BONE, THE INSERTER SNAPPED COMPLETELY, LEAVING A PORTION OF THE INSERTER LODGED INSIDE THE ANCHOR. THE SURGEON ATTEMPTED TO REMOVE THE RETAINED INSERTER FRAGMENT BUT WAS UNSUCCESSFUL AND ELECTED TO LEAVE BOTH THE ANCHOR AND THE FRAGMENT IMPLANTED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 16-JAN-2026: THE SURGERY OCCURRED ON (B)(6) 2026. THE CASE WAS COMPLETED USING A REPLACEMENT AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT. ALTHOUGH THE SURGERY ITSELF WAS NOT DELAYED, APPROXIMATELY 10 MINUTES WERE SPENT ATTEMPTING TO REMOVE THE FRAGMENT, BUT THE FRAGMENT WAS LEFT IN PLACE.
Patient problems: Foreign Body In Patient
MAUDE report 24245184 ↗MalfunctionOct 15, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1927BCT-475, SUTURE ANCHOR, BIOCOMPOSITE¿ CORKSCREW® FT, DOUBLE LOADED WITH TWO 1.3 MM SUTURETAPE¿, 4.75 MM, BOTH THE IMPLANTS BROKE INTRA OPERATION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW ANCHOR.
Patient problems: Insufficient Information
MAUDE report 23303719 ↗MalfunctionOct 15, 2025Break; Break
ON 13TH OCT 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNITS OF AR-1927BCT-475, SUTURE ANCHOR, BIOCOMPOSITE¿ CORKSCREW® FT, DOUBLE LOADED WITH TWO 1.3 M M SUTURETAPE¿, 4.75 MM, BOTH THE IMPLANTS BROKE INTRA OPERATION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW ANCHOR.
Patient problems: Insufficient Information
MAUDE report 23302777 ↗MalfunctionNov 26, 2024Break; Crack; Break; Crack
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT WAS CRACKED AND BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20789700 ↗MalfunctionJun 24, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ON 05/28/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT HAD A SMALL LOOP OF WHITE THREAD INSIDE THE ANCHOR PROTRUDED FROM THE REAR END OF THE ANCHOR, AND THE ANCHOR SUTURE WAS FLOATING FROM THE ANCHOR. THE SURGEON ATTEMPTED TO REMOVE THE ANCHOR BUT WAS UNABLE TO. ANOTHER BONE SOCKET WAS DRILLED AND AN AR-1927BCT BIOCOMPOSITE CORKSCREW FT WAS INSERTER. HOWEVER, THE SAME THING HAPPENED WITH THIS ANCHOR. THE CASE WAS COMPLETED USING AN AR-3633SP FIBERTAK SP. THIS WAS DISCOVERED DURING A PROCEDURE WHEN SUTURING A ROTATOR CUFF TEAR ON (B)(6) 2024.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 19592799 ↗MalfunctionApr 29, 2024Break; Break
ON 11/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (3) AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHORS FAILED. ONE FAILED ON THE FIRST THREAD, THE SECOND FAILED WHEN THE DRIVER SNAPPED, AND THE THIRD CRACKED ABOUT HALFWAY IN. SURGEON ELECTED TO USE BONE TUNNELS IN LIEU OF SUTURE ANCHORS TO COMPLETE THE CASE. ADDITIONAL INFORMATION RECEIVED ON 11/14/2022: THIS WAS DISCOVERED DURING A QUAD TENDON REPAIR ON (B)(6) 2022. AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHOR, FROM LOT NUMBER 10494037, BROKE WHEN SCREWING IT IN ON THE FIRST TORQUE. ANOTHER AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT INSERTER BROKE WHILE SURGEON WAS ATTEMPTING TO IMPLANT THE SCREW, THE TORQUE WAS TOO MUCH ON THE INSERTER. THE ANCHOR ITSELF DID NOT BREAK BUT IT WAS REMOVED FROM THE PATIENT. THE INSERTER DID NOT BREAK INSIDE THE PATIENT. A THIRD AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHOR BROKE AND ALL FRAGMENTS WERE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 19205507 ↗MalfunctionApr 9, 2024Break; Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (3) AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHORS FAILED. ONE FAILED ON THE FIRST THREAD, THE SECOND FAILED WHEN THE DRIVER SNAPPED, AND THE THIRD CRACKED ABOUT HALFWAY IN. SURGEON ELECTED TO USE BONE TUNNELS IN LIEU OF SUTURE ANCHORS TO COMPLETE THE CASE. ADDITIONAL INFORMATION RECEIVED ON 11/14/2022: THIS WAS DISCOVERED DURING A QUAD TENDON REPAIR ON (B)(6) 2022. AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHOR, FROM LOT NUMBER 10494037, BROKE WHEN SCREWING IT IN ON THE FIRST TORQUE. ANOTHER AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT INSERTER BROKE WHILE SURGEON WAS ATTEMPTING TO IMPLANT THE SCREW, THE TORQUE WAS TOO MUCH ON THE INSERTER. THE ANCHOR ITSELF DID NOT BREAK BUT IT WAS REMOVED FROM THE PATIENT. THE INSERTER DID NOT BREAK INSIDE THE PATIENT. A THIRD AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHOR BROKE AND ALL FRAGMENTS WERE RETRIEVED.
Patient problems: Insufficient Information
MAUDE report 19072486 ↗MalfunctionApr 8, 2024Break; Break
ON 3/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHORS BROKE DURING IMPLANTATION. THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING SWIVELOCKS. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19061103 ↗MalfunctionApr 8, 2024Break; Break
ON 3/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHORS BROKE DURING IMPLANTATION. THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING SWIVELOCKS. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19061078 ↗MalfunctionApr 8, 2024Break; Break
ON 3/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHORS BROKE DURING IMPLANTATION. THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING SWIVELOCKS. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19061035 ↗MalfunctionFeb 27, 2024Break; Break
ON 2/7/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) AR-1927BCT-475 BIOCOMPOSITE CORKSCREW BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. TWO ADDITIONAL AR-1927BCT-475 BIOCOMPOSITE CORKSCREWS WERE USED TO COMPLETE THE CASE. ALL THE BROKEN FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 2/13/2024: THE CASE WAS DELAYED ABOUT SIX MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18788109 ↗MalfunctionFeb 27, 2024Break; Break
ON 2/7/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (2) AR-1927BCT-475 BIOCOMPOSITE CORKSCREW BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. TWO ADDITIONAL AR-1927BCT-475 BIOCOMPOSITE CORKSCREWS WERE USED TO COMPLETE THE CASE. ALL THE BROKEN FRAGMENTS WERE RETRIEVED AND THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 2/13/2024: THE CASE WAS DELAYED ABOUT SIX MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18788055 ↗MalfunctionJan 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 01/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-1927BCT-475 SUTURE ANCHOR PULLED OUT. THIS OCCURRED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 18608892 ↗MalfunctionJan 23, 2024Break; Break
ON 01/04/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1927BCT-475 SUTURE ANCHOR METAL TIP BROKE OFF TWO ANCHORS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18565445 ↗MalfunctionJan 23, 2024Break; Break
ON 01/04/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1927BCT-475 SUTURE ANCHOR METAL TIP BROKE OFF TWO ANCHORS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18564616 ↗MalfunctionJan 10, 2024Crack; Crack
ADDITIONAL INFORMATION WAS PROVIDED ON 12/19/2023 WHERE THE ARTHREX SUBSIDIARY EMPLOYEE STATED THAT THIS EVENT OCCURRED DURING AN ARCR PROCEDURE. AN AR-1927PB WAS USED TO PREPARE THE BONE SOCKET FOR INSERTION. THE PATIENT HAD A HARD BONE QUALITY. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18482950 ↗MalfunctionSep 27, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1927BCT-475 SUTURE ANCHOR BROKE WHILE BEING INSERTED INTO THE BONE, SOON AS THE ANCHOR STARTED THE ANCHOR BROKE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT. DELAY LESS THAN 15 MINUTES. PROCEDURE COMPLETED USING ANOTHER ANCHOR.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17827163 ↗MalfunctionSep 26, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1927BCT-475 SUTURE ANCHOR, BIOCOMPOSITE CORKSCREW, HAD AN ISSUE. WHEN INSERTING THE SUTURE ANCHOR, THE SURGEON PUNCHED AND TAPPED, AND THE ANCHOR BROKE. THE ANCHOR WAS REMOVED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT, AND THE CASE WAS DELAYED LESS THAN 10 MINUTES. THE CASE WAS COMPLETED SUCCESSFULLY USING ANOTHER AR-1927BCT-475 SUTURE ANCHOR. THIS WAS DISCOVERED DURING A ROTARY CUFF REPAIR PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17817059 ↗MalfunctionAug 31, 2023Break; Break
ON 8/4/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT (2) AR-3632SP FIBERTAK SP AND AN AR-1927BCT-475 BIOCOMPOSITE CORKSCREW BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17663472 ↗MalfunctionMay 11, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED, BY A DISTRIBUTOR VIA SEMS. THAT (2) AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHORS BROKE, WHILE BEING SCREWED INTO THE BONE HOLE ON THE INITIAL TURN. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16914569 ↗MalfunctionMar 27, 2023Break; Break
ON (B)(6), 2023, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT AN AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHOR PARTIALLY BROKE WHILE BEING SCREWED INTO THE BONE HOLE. THE ANCHOR AND SUTURES WERE RETRIEVED FROM INSIDE THE PATIENT AND ANOTHER AR-1927BCT-475 BIOCOMPOSITE CORKSCREW FT ANCHOR WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6), 2023.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16617824 ↗MalfunctionFeb 16, 2023Break; Difficult to Remove
ON 1/30/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927BCT-475 BIO-COMPOSITE CORKSCREW FT INSERTER SNAPPED IN HALF DURING INSERTION. A MAJORITY OF THE INSERTER WAS REMOVED, BUT A PORTION OF IT WAS LODGED WITHIN THE BODY OF THE CORKSCREW. EFFORTS WERE MADE TO REMOVE THE INSERTER FROM WITHIN THE ANCHOR, BUT THAT WAS UNSUCCESSFUL GIVEN IT WAS BURIED WITHIN THE CORKSCREW ANCHOR. SURGEON ALSO TRIED TO REMOVE THE CORKSCREW, BUT AFTER MULTIPLE ATTEMPTS, IT WAS DECIDED TO LEAVE IT IN, GIVEN IT WAS SEATED WELL WITHIN THE BONE AND REMOVAL COULD HAVE LED TO SIGNIFICANT BONE LOSS. THE ANCHOR REMAINED INTACT AND DID NOT BREAK IN ANY MANNER. A 2.9 MM PUSHLOCK WAS UTILIZED TO COMPLETE THE REMPLISSAGE OPPOSED TO THE 4.75 MM CORKSCREW. THE PUSHLOCK WAS PLACED NEXT TO THE 4.75 MM CORKSCREW ANCHOR TO TRY AND MAINTAIN THE DESIRED POSITION OF THE ANCHOR. THIS WAS DISCOVERED DURING A REMPLISSAGE AND LABRAL REPAIR OF THE SHOULDER PROCEDURE ON (B)(6) 2023.
Patient problems: Foreign Body In Patient
MAUDE report 16385117 ↗MalfunctionNov 22, 2022Break; Crack
ON 11/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-1927BCT-475 BIO-COMPOSITE CORKSCREW FT ANCHORS FAILED. ONE FAILED ON THE FIRST THREAD, THE SECOND FAILED WHEN THE DRIVER SNAPPED, AND THE THIRD CRACKED ABOUT HALFWAY IN. SURGEON ELECTED TO USE BONE TUNNELS IN LIEU OF SUTURE ANCHORS TO COMPLETE THE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15842884 ↗MalfunctionNov 22, 2022Break; Crack
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (3) AR-1927BCT-475 MALFUNCTIONED. THIS OCCURRED DURING A CASE WHEN THE SURGEON ATTEMPTED TO USE THREE SEPARATE 4.75 CORKSCREWS FOR A QUAD TENDON REPAIR. ALL THREE OF THE CORKSCREWS FAILED. ONE FAILED ON THE FIRST THREAD, THE SECOND FAILED WHEN THE DRIVER SNAPPED, AND THE THIRD CRACKED ABOUT HALFWAY IN. THE CASE WAS COMPLETED USING BONE TUNNELS IN LIEU OF SUTURE ANCHORS. THERE WAS NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15842880 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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