Arthrex® AR-2923BCRecalls & reported problems
Arthrex, Inc. · SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex AR-2923BC BioComposite PushLock suture anchor is a biodegradable soft-tissue fixation anchor used in shoulder and labrum surgery. The 49 reports mostly describe the anchor or its eyelet breaking or cracking during insertion or surgery, sometimes leaving fragments that had to be retrieved from the patient. There are no deaths and 12 injuries. No recalls name this device. Reports dropped from 10 in the prior 12 months to 2 in the most recent 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
- 49
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00888867099203), received between Aug 30, 2016 and Jul 30, 2026 — classified as 12 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Break” (39 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
- Break39
- Patient-Device Incompatibility3
- Crack2
- Detachment of Device or Device Component1
- Device Fell1
- Material Fragmentation1
- Material Integrity Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information14
- Foreign Body In Patient5
- Fatigue2
- Malaise2
- No Information2
- Complaint, Ill-Defined1
- Cyst(s)1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087053 ↗MalfunctionJul 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087019 ↗MalfunctionOct 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE IMPLANT DID NOT SEPARATE FROM THE DRIVER. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23313172 ↗MalfunctionJul 3, 2025Break; Break
ON 06/09/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2923BC BIOCOMPOSITE PUSHLOCK ANCHOR HAD THE TIP OF THE EYELET BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER AR-2923BC BIOCOMPOSITE PUSHLOCK ANCHOR. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 06/23/2025: THIS ISSUE OCCURRED UPON IMPLANT INSERTION ON THE PATIENT DURING AN ARTHROSCOPIC BANKART REPAIR ON (B)(6) 2025. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO CASE DELAY, AND NO ADDED ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22396698 ↗MalfunctionMay 21, 2025Break; Break
ON 05/02/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2923BC SUTURE ANCHOR BROKE IN HALF UPON IMPLANTATION. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS DELAYED LESS THAN 15 MINUTES WITH 2-3 MINUTES OF ADDED ANESTHESIA. THIS WAS DISCOVERED DURING A ROTATOR CUFF PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060018 ↗MalfunctionFeb 4, 2025Break; Break
ON (B)(6) 2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-2923BC BIOCOMPOSITE PUSHLOCK SL ANCHOR WAS FOUND DEFECTIVE AND BROKE OFF PRIOR TO IMPLANTATION IN THE PATIENT'S SHOULDER. THE SURGEON TURNED OFF THE OUTFLOW, AND UPON FURTHER ASSESSMENT, THE ANCHOR COULD NO LONGER BE FOUND. THE PATIENT'S SHOULDER WAS SEARCHED FOR THE ANCHOR. THE ANCHOR WAS UNABLE TO BE OBTAINED, AND A NEW ANCHOR WAS OPENED. IT WAS DOCUMENTED THAT THE ANCHOR WAS IMPLANTED, AS IT REMAINED WITHIN THE SHOULDER. THIS WAS DISCOVERED DURING A PROCEDURE IN (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 1/20/2025: THIS WAS DISCOVERED DURING A RIGHT SHOULDER ARTHROSCOPIC, ANTERIOR LABRAL REPAIR, AND SLAP REPAIR PROCEDURE ON (B)(6) 2024. THE NEW ANCHOR USED TO COMPLETE THE CASE WAS ALSO AN AR-2923BC BIOCOMPOSITE PUSHLOCK SL. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 21305118 ↗MalfunctionJan 6, 2025Break; Break
ON 12/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE EYELETS OF THREE AR-2923BC BIOCOMPOSITE PUSHLOCK EYELETS BROKE OFF WHILE BARELY INSERTING THE ANCHOR INTO THE BONE. EVERYTHING WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING 1.8 KNOTLESS FIBERTAK DEVICES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED 12/16/2024.
Patient problems: Insufficient Information
MAUDE report 21080329 ↗MalfunctionJan 6, 2025Break; Break
ON 12/9/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE EYELETS OF THREE AR-2923BC BIOCOMPOSITE PUSHLOCK EYELETS BROKE OFF WHILE BARELY INSERTING THE ANCHOR INTO THE BONE. EVERYTHING WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING 1.8 KNOTLESS FIBERTAK DEVICES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED 12/16/2024.
Patient problems: Insufficient Information
MAUDE report 21080181 ↗MalfunctionJan 6, 2025Break; Break
ADDITIONAL INFORMATION RECEIVED ON 12/18/20254: THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE. THE ANCHORS WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-3636 KNOTLESS FIBERTAK. THE CASE WAS DELAYED TWENTY MINUTES WITHOUT ADDITIONAL ANESTHESIA.
Patient problems: Insufficient Information
MAUDE report 21080111 ↗MalfunctionDec 30, 2024Break; Break
ON 12/3/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2923BC BIOCOMPOSITE PUSHLOCK EYELET BROKE OFF AFTER INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21034954 ↗MalfunctionDec 30, 2024Break; Break
ON 12/3/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2923BC BIOCOMPOSITE PUSHLOCK EYELET BROKE OFF AFTER INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21034948 ↗MalfunctionNov 19, 2024Break; Break
ON 11/4/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2923BC BIOCOMPOSITE PUSHLOCK SL EYELET HAD PULLED THROUGH THE ANCHOR AFTER BEING INSERTED AND BEFORE CUTTING THE SUTURE. THIS CAUSED THE SUTURE TO NOT REMAIN FIXATED. THE ANCHORS WERE LEFT IN THE BONE, AND A SECOND ANCHOR HAD TO BE OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED. ADDITIONAL INFORMATION RECEIVED ON 11/7/2024: THE CASE WAS COMPLETED USING ANOTHER AR-2923BC BIOCOMPOSITE PUSHLOCK SL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20727417 ↗MalfunctionOct 31, 2024Break; Break
ON 10/17/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT A (QTY. (B)(4) OF AN AR-2923BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE IN PIECES DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER OF THE SAME PRODUCT FROM A DIFFERENT LOT WITH NO ISSUES. ALL PIECES WERE RETRIEVED SUCCESSFULLY FROM THE PATIENT. THE CASE WAS DELAYED 30 MINUTES WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20578440 ↗MalfunctionOct 31, 2024Break; Break
ON 10/17/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT A (QTY. (B)(4) OF AN AR-2923BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE IN PIECES DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER OF THE SAME PRODUCT FROM A DIFFERENT LOT WITH NO ISSUES. ALL PIECES WERE RETRIEVED SUCCESSFULLY FROM THE PATIENT. THE CASE WAS DELAYED 30 MINUTES WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20578171 ↗MalfunctionOct 31, 2024Break; Break
ON 10/17/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT A (QTY. 5) OF AN AR-2923BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE IN PIECES DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER OF THE SAME PRODUCT FROM A DIFFERENT LOT WITH NO ISSUES. ALL PIECES WERE RETRIEVED SUCCESSFULLY FROM THE PATIENT. THE CASE WAS DELAYED 30 MINUTES WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20578021 ↗MalfunctionOct 31, 2024Break; Break
ON 10/17/2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT A (QTY. (B)(4) OF AN AR-2923BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE IN PIECES DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER OF THE SAME PRODUCT FROM A DIFFERENT LOT WITH NO ISSUES. ALL PIECES WERE RETRIEVED SUCCESSFULLY FROM THE PATIENT. THE CASE WAS DELAYED 30 MINUTES WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577971 ↗MalfunctionOct 31, 2024Break; Break
ON (B)(6)2024, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT A (QTY. (B)(4)) OF AN AR-2923BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE IN PIECES DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER OF THE SAME PRODUCT FROM A DIFFERENT LOT WITH NO ISSUES. ALL PIECES WERE RETRIEVED SUCCESSFULLY FROM THE PATIENT. THE CASE WAS DELAYED 30 MINUTES WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6)2024, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577874 ↗MalfunctionJul 25, 2024Break; Break
ON 07/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2923BC BIOCOMPOSITE PUSHLOCK HANDLE BROKE. WHEN MALLETING ANCHOR INTO THE PILOT HOLE ON THE GLENOID, THE METAL IMPACTOR BROKE OFF THE BACK OF THE ANCHOR. THE ANCHOR WOULD NOT UNTHREAD, HAD TO BE PULLED OUT FORCEFULLY IN ORDER TO REMOVE THE INSERTER FROM ANCHOR EYELET. THE ANCHOR AND EYELET WERE ABLE TO BE IMPLANTED SUCCESSFULLY TO COMPLETE THE CASE. AFTER ASSESSING THE ANCHOR INSERTER ON THE BACK TABLE, IT APPEARED AS THE INNERMOST PORTION OF THE ANCHOR INSERTER THAT THREADS INTO THE EYELET, RECESSED INTO THE OUTER INSERTION SLEEVE OF THE HANDLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19832323 ↗MalfunctionJul 25, 2024Break; Break
ON 07/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2923BC BIOCOMPOSITE PUSHLOCK HANDLE BROKE. WHEN MALLETING ANCHOR INTO THE PILOT HOLE ON THE GLENOID, THE METAL IMPACTOR BROKE OFF THE BACK OF THE ANCHOR. THE ANCHOR WOULD NOT UNTHREAD, HAD TO BE PULLED OUT FORCEFULLY IN ORDER TO REMOVE THE INSERTER FROM ANCHOR EYELET. THE ANCHOR AND EYELET WERE ABLE TO BE IMPLANTED SUCCESSFULLY TO COMPLETE THE CASE. AFTER ASSESSING THE ANCHOR INSERTER ON THE BACK TABLE, IT APPEARED AS THE INNERMOST PORTION OF THE ANCHOR INSERTER THAT THREADS INTO THE EYELET, RECESSED INTO THE OUTER INSERTION SLEEVE OF THE HANDLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19832011 ↗MalfunctionJun 19, 2024Break; Break
IT WAS REPORTED THAT THE AR-2923BC ANCHOR'S TIP BROKE OFF AND THE SUTURE PASSER KNOTTED UP THE SUTURES. THE FACILITY REPORTED THE DEVICE BROKE PRIOR TO BEING USED ON THE PATIENT. THE CASE WAS COMPLETED BY USING ANOTHER ITEM. SEE SOURCE DATA AND IMAGE ATTACHED.
Patient problems: Insufficient Information
MAUDE report 19566199 ↗MalfunctionApr 17, 2024Break; Break
ON 3/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2923BC BIOCOMPOSITE PUSHLOCK ANCHOR SPLIT IN HALF DURING INSERTION. THE BROKEN FRAGMENTS WERE REMOVED, AND ANOTHER ANCHOR WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A SLAP REPAIR PROCEDURE ON 3/21/2024. ADDITIONAL INFORMATION RECEIVED ON 3/27/2024: THE CASE WAS NOT DELAYED AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19126399 ↗MalfunctionMar 21, 2024Break; Break
ON 03/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-2923BC SUTURE ANCHORS EYELET BROKE. THIS OCCURRED DURING AN ANTERIOR BANKART PROCEDURE WHERE THEY USED AN AR-2923DS TO DRILL A PILOT HOLE FOR THE ANCHOR. A SUTURETAPE WAS PASSED AROUND THE LABRUM USING A LABRAL SCORPION AND THE SUTURE WAS LOADED ONTO THE AR-2923BC ANCHOR. THE DEVICE WAS INSERTED INTO THE PILOT HOLE AND THE SLACK WAS PULLED OUT, WHEN THE SURGEON MALLETED THE ANCHOR DOWN TO BONE THE SUTURES CAME LOOSE, SO HE PULLED THE ANCHOR OUT AND THE EYELET BROKE AT THE TIP AND WOULD NO LONGER HOLD ONTO THE SUTURETAPE. THEY WERE ABLE TO COMPLETE THE REPAIR WITH ANOTHER AR-2923BC. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 18951418 ↗MalfunctionMar 14, 2024Break; Break
IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE 5 PUSHLOCKS AS-2923BC (LOT: 14998931) BROKEN OFF DURING INSERTION. ALL FRAGMENTS COULD BE RETRIEVED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18904251 ↗MalfunctionMar 14, 2024Break; Break
IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE 5 PUSHLOCKS AS-2923BC (LOT: 14998931) BROKEN OFF DURING INSERTION. ALL FRAGMENTS COULD BE RETRIEVED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18904225 ↗MalfunctionMar 14, 2024Break; Break
IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE 5 PUSHLOCKS AS-2923BC (LOT: 14998931) BROKEN OFF DURING INSERTION. ALL FRAGMENTS COULD BE RETRIEVED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18904142 ↗
Other FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE devices
- GRYPHON ORTHOCORD 210813Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE712 reports
- HEALIX ADVANCE 222330Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- 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 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