Arthrex® AR-1922BCRecalls & reported problems
Arthrex, Inc. · SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex Biocomposite PushLock suture anchor is a biodegradable soft-tissue fixation anchor used in shoulder and rotator cuff repair surgery. Most of the 32 reports describe the anchor or its eyelet breaking, usually during insertion or while being pulled out, sometimes leaving fragments in the patient; a few describe anchors that would not advance or came loose. There are no deaths and 2 injuries, and 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
- 32
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00888867022874), received between Nov 2, 2017 and Jan 22, 2026 — classified as 2 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Break” (25 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
- Break25
- Device Dislodged or Dislocated2
- Failure to Advance2
- Activation Failure1
- Entrapment of Device1
- Insufficient Device Problem Information1
- Material Twisted/Bent1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- Insufficient Information9
- Failure of Implant3
- Pain3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Device Embedded In Tissue or Plaque1
- Dizziness1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2026Patient Device Interaction Problem
UPDATE 26-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: UPON REVIEWING THE SURGICAL IMAGES FROM (B)(6) 2022, THE SURGEON HAS NOT NOTICED ANY ABNORMALITIES SO FAR. IT IS NOT POSSIBLE TO CONCLUSIVELY DETERMINE WHETHER THE SYMPTOMS DESCRIBED BY THE PATIENT WERE CAUSED BY A MEDICAL DEVICE. IN ADDITION, THE SURGEON CONFIRMED THAT NO BROKEN PIECES OR METAL DEBRIS FROM THE BURR REMAINED INSIDE THE PATIENT.
Patient problems: Dizziness; Nausea; Pain
MAUDE report 24144237 ↗MalfunctionSep 19, 2025Break; Break
ON 2ND SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 4.5 X 24 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A SHOULDER INSTABILITY SURGERY REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1922BC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095756 ↗MalfunctionSep 19, 2025Break; Break
ON 2ND SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 4.5 X 24 MM, THE END OF THE ANCHOR BROKE. THIS WAS DETECTED DURING A SHOULDER INSTABILITY SURGERY REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1922BC. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23095554 ↗MalfunctionAug 13, 2025Failure to Advance; Failure to Advance
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 4.5 X 24 MM, BOTH ITS ANCHOR BROKE DURING INSERTION. THE 1ST UNIT OF AR-1922BC'S ANCHOR BROKE DURING INSERTION AND ANOTHER AR-1922BC WAS CHANGED TO BUT THE SAME ISSUE HAPPENED. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1922BC. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22794646 ↗MalfunctionAug 13, 2025Failure to Advance; Failure to Advance
ON 29TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 2 UNITS OF AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 4.5 X 24 MM, BOTH ITS ANCHOR BROKE DURING INSERTION. THE 1ST UNIT OF AR-1922BC'S ANCHOR BROKE DURING INSERTION AND ANOTHER AR-1922BC WAS CHANGED TO BUT THE SAME ISSUE HAPPENED. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1922BC. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22794644 ↗MalfunctionMar 19, 2025Break; Break
ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 4.5 X 24 MM, BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1922BC. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21643762 ↗MalfunctionDec 31, 2024Break; Break
ON 5TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK ANCHOR EYELET BROKE DURING IMPLANTATION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2024. AR-1922P WAS USED TO PREPARE BONE SOCKET. THE EYELET OF THE IMPLANT BROKE DURING IMPLANTATION. NO FRAGMENTS WERE LEFT IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER PRODUCT AR-2324BCC INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048626 ↗MalfunctionDec 30, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK ANCHOR BROKE WHILE PULLING IT OUT. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024. AR-1922P WAS USED TO PREPARE BONE SOCKET AND THE ANCHOR BROKE WHILE PULLING IT OUT. THE BROKEN PIECES WERE LEFT INSIDE PATIENT. FRAGMENTS WERE NOT RETRIEVED. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 21034138 ↗MalfunctionSep 26, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 4.5 X 24 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN A CUFF ROTATOR REPAIR PROCEDURE ON (B)(6) 2024. ALL THE FRAGMENTS HAVE BEEN RETRIEVED FROM PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1922BC. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20310713 ↗MalfunctionSep 17, 2024Break; Break
ON 4TH SEPTEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 4.5 X 24 MM, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2024. ALL THE FRAGMENTS HAVE BEEN RETRIEVED FROM PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1922BC. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20236915 ↗MalfunctionSep 17, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 4.5 X 24 MM'S CONNECTING POLE BROKE DURING A ROTATOR CUFF REPAIR PROCEDURE. ALL THE FRAGMENTS HAVE BEEN RETRIEVED FROM PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A NEW AR-1922BC. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235491 ↗MalfunctionSep 16, 2024Break; Break
ON 3RD SEP 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1922BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 4.5 X 24 MM'S CONNECTING POLE BROKE DURING A ROTATOR CUFF REPAIR PROCEDURE. ALL THE FRAGMENTS HAVE BEEN RETRIEVED FROM PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY SUING A NEW AR-1922BC. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20226761 ↗MalfunctionJun 13, 2024Break; Break
IT WAS REPORTED THAT DURING A ROTATOR SUTURE SURGERY WHILE INSERTING THE IMPLANT IT GOT BENT AND BROKE INTO TWO PIECES. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. UPDATE 10-MAR-2021 DW FURTHER INFORMATION WERE PROVIDED THAT THE ANCHOR BROKE INTO TWO PIECES WHILE IT REMAINED ON THE RAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19534408 ↗MalfunctionMay 8, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1922BC BIOCOMPOSITE PUSHLOCK EYELET BROKE DURING INSERTION. THIS OCCURRED WHEN FIXING THE SUPRASPINATUS TENDON WITH EXTERNAL FIXATION. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING AAR-1922BC BIOCOMPOSITE PUSHLOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. THE PATIENT SUFFERED NO NEGATIVE EFFECTS. ADDITIONAL INFORMATION RECEIVED ON 4/23/2024: THE CASE WAS DELAYED TWENTY MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19268248 ↗MalfunctionFeb 26, 2024Break; Break
ON 2/05/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1922BC SUTURE ANCHOR BROKE DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER NEW AR-1922BC SUTURE ANCHOR WITH NO SECONDARY PROCEDURE NEEDED. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2024..
Patient problems: Insufficient Information
MAUDE report 18776554 ↗MalfunctionJan 4, 2024Break; Break
ON 12/11/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1922BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1922BC BIOCOMPOSITE PUSHLOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS DELAYED FIFTEEN MINUTES; HOWEVER, NO ADDITIONAL ANESTHESIA WAS NEEDED. ADDITIONAL INFORMATION RECEIVED ON 12/18/2023: THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18444267 ↗MalfunctionDec 15, 2023Break; Break
ON 11/20/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1922BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED BY REMOVING ALL FRAGMENTS AND USING A NEW AR-1922BC BIOCOMPOSITE PUSHLOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 11/24/2023: NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18340839 ↗MalfunctionDec 15, 2023Break; Break
ON 11/20/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1922BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED BY REMOVING ALL FRAGMENTS AND USING A NEW AR-1922BC BIOCOMPOSITE PUSHLOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 11/24/2023: THE CASE WAS NOT DELAYED, AND NO ADDITIONAL ANESTHESIA WAS NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18340835 ↗MalfunctionNov 29, 2023Break; Break
ON 11/2/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1922BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED WITH A NEW AR-1922BC BIOCOMPOSITE PUSHLOCK FROM THE SAME LOT NUMBER. THE CASE WAS DELAYED ABOUT FIVE MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON 10/19/2023.
Patient problems: Insufficient Information
MAUDE report 18226866 ↗MalfunctionOct 13, 2023Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1922BC BIOCOMPOSITE PUSHLOCK EYELET BENT DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1922BC BIOCOMPOSITE PUSHLOCK. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 9/26/2023: THIS WAS DISCOVERED DURING AN RCR PROCEDURE.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 17933995 ↗MalfunctionOct 13, 2023Break; Break
ON 9/19/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1922BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-1922BC BIOCOMPOSITE PUSHLOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 9/20/2023: THERE WAS NO DELAY IN THE PROCEDURE, AND NO ADDITIONAL INFORMATION WAS ADMINISTERED TO THE PATIENT. THE PATIENT DID NOT SUFFER ANY NEGATIVE EFFECTS OR SIGNIFICANT DAMAGES.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17929174 ↗MalfunctionAug 29, 2023Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE DEVICE BROKE INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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. *** UPDATE 14-AUG-2023 NROEMER: FURTHER INFORMATION REVEALED THAT THE TIP OF THE DEVICE BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17646118 ↗MalfunctionAug 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 7/27/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-1922BC BIOCOMPOSITE PUSHLOCK ANCHOR PULLED OUT. THIS WAS DISCOVERED WHEN THE SURGEON TRIED TO FIX THE LATERAL ROW WITH THE PUSHLOCK ANCHOR DURING AN RCR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED. PART NUMBER WAS UPDATED 08/24/2023 TO (QTY.2) AR-1926BC BIOCOMPOSITE PUSHLOCK, AS THIS WAS THE COMPLAINT DEVICE AND NOT (2) AR-1922BC.
Patient problems: Insufficient Information
MAUDE report 17611558 ↗MalfunctionAug 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON 7/27/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT (2) AR-1922BC BIOCOMPOSITE PUSHLOCK ANCHOR PULLED OUT. THIS WAS DISCOVERED WHEN THE SURGEON TRIED TO FIX THE LATERAL ROW WITH THE PUSHLOCK ANCHOR DURING AN RCR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED. PART NUMBER WAS UPDATED 08/24/2023 TO (QTY.2) AR-1926BC BIOCOMPOSITE PUSHLOCK, AS THIS WAS THE COMPLAINT DEVICE AND NOT (2) AR-1922BC.
Patient problems: Insufficient Information
MAUDE report 17610428 ↗MalfunctionMar 24, 2023Break; Break
ON 3/7/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AR-1922BC BIOCOMPOSITE PUSHLOCK ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED WITH ANOTHER AR-1922BC BIOCOMPOSITE PUSHLOCK. THIS WAS DISCOVERED DURING AN ACL PROCEDURE ON (B)(6) 2023. ALL BROKEN PIECES WERE REMOVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16609072 ↗
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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.
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