Arthrex® AR-8825BCRecalls & reported problems
Arthrex, Inc. · Suture Anchor, Mini BC PushLock · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867247901), received between Sep 14, 2021 and Aug 27, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Detachment of Device or Device Component2
- Crack1
- Expiration Date Error1
- Failure to Advance1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions6
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Failure to Advance
On 13-Aug-2026, a sales representative reported via email that an AR-8825BC Mini BioComposite PushLock Suture Anchor (2.5 mm × 8 mm) experienced an issue during a procedure performed on (b)(6) 2026. While inserting the anchor for a repair, the surgeon placed the anchor into bone hole and removed the orange tab. When attempting to seat the anchor by malleting the driver, the driver would not advance. Multiple attempts were made, but the driver remained unable to advance the anchor. The patient outcome was not reported.Additional information was received on (b)(6) 2026:The procedure being performed was a wrist arthroscopy with TFCC repair. The eyelet was fully seated in the bone; however, the anchor would not advance further into the bone. No excessive resistance was encountered during insertion, and no visible damage was observed on either the anchor or the driver.The affected implant was removed. The eyelet could not be removed and remained implanted in the patient. Another AR-8825BC was used to successfully complete the procedure. The event did not result in a surgical delay beyond the time required to open a replacement implant, and no additional anesthesia was administered.No br
Patient problems: Foreign Body In Patient
MAUDE report 50473843 ↗MalfunctionSep 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 08/27/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8825BC BIOCOMPOSITE PUSHLOCK MINI SUTURE ANCHOR BECAME UNUSABLE WHEN THE TIP OF THE ANCHOR DETACHED AS THE TAPE WAS SUTURED THROUGH. THE SURGERY WAS COMPLETED USING A REPLACEMENT AR-8825BC BIOCOMPOSITE PUSHLOCK MINI SUTURE ANCHOR. NO BREAKAGE OCCURRED WITHIN THE PATIENT DURING USE. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED. THIS ISSUE WAS IDENTIFIED DURING A PROCEDURE PERFORMED ON (B)(6) 2025, WITH NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084041 ↗MalfunctionMar 19, 2024Break; Break
IT WAS REPORTED THAT DURING A BROSTRÖM/GOULD EXTERNAL LIGAMENT RECONSTRUCTION SURGERY THE DEVICE BROKE OFF DURING INSERTION. THE SECOND INSERTED ANCHOR ALSO BROKE OFF. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18934929 ↗MalfunctionFeb 1, 2024Break; Break
ON 01/11/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8825BC MINI PUSH LOCK BROKE DURING INSERTION. ALL FRAGMENTS REMOVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18624514 ↗MalfunctionJan 25, 2024Expiration Date Error; Expiration Date Error
ON 1/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8825BC BIOCOMPOSITE PUSHLOCK WAS IMPLANTED IN A PATIENT AFTER ITS EXPIRATION DATE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 18581641 ↗MalfunctionJan 2, 2024Break; Break
ON 12/4/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (4) AR-8825BC BIOCOMPOSITE PUSHLOCK MINI SUTURE ANCHOR BROKE DURING INSERTION. THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A TFCC PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18431007 ↗MalfunctionJan 2, 2024Break; Break
ON 12/4/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (4) AR-8825BC BIOCOMPOSITE PUSHLOCK MINI SUTURE ANCHOR BROKE DURING INSERTION. THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A TFCC PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18430995 ↗MalfunctionJan 2, 2024Break; Break
ON 12/4/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (4) AR-8825BC BIOCOMPOSITE PUSHLOCK MINI SUTURE ANCHOR BROKE DURING INSERTION. THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A TFCC PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18430980 ↗MalfunctionJan 2, 2024Break; Break
ON 12/4/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT (4) AR-8825BC BIOCOMPOSITE PUSHLOCK MINI SUTURE ANCHOR BROKE DURING INSERTION. THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING PRODUCTS FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING A TFCC PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information
MAUDE report 18430977 ↗MalfunctionAug 30, 2023Break; Break
IT WAS REPORTED THAT DURING A BROSTRÖM/GOULD EXTERNAL LIGAMENT RECONSTRUCTION SURGERY THE DEVICE BROKE OFF DURING INSERTION. THE SECOND INSERTED ANCHOR ALSO BROKE OFF. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17652390 ↗MalfunctionApr 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON 3/14/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8825BC MINI BIOCOMPOSITE PUSHLOCK DISTAL EYELET AND SCREW PORTION WERE DETACHED FROM THE ANCHOR SHAFT. NO BROKEN PIECE REMAINS IN THE BODY. ANOTHER PRODUCT WAS OPENED, AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16715999 ↗MalfunctionOct 24, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN (4) AR-8825BC BIOCOMPOSITE PUSHLOCK WERE BEING USED IN A PROCEDURE. TWO OF THE FOUR BROKE WHEN THREADING THE TAPES THROUGH THE EYELET AND ANOTHER HAD THE SCREW BREAK WHEN IT WAS BEING INSERTER IN THE BONE HOLE. ADDITIONAL INFORMATION RECEIVED 10/6/2022: TWO OF THE PUSHLOCK'S EYELETS BROKE WHEN PASSING THE SUTURES THROUGH; THIS WAS OUTSIDE OF THE PATIENT, PRIOR TO INSERTION. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15657469 ↗MalfunctionOct 24, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN (4) AR-8825BC BIOCOMPOSITE PUSHLOCK WERE BEING USED IN A PROCEDURE. TWO OF THE FOUR BROKE WHEN THREADING THE TAPES THROUGH THE EYELET AND ANOTHER HAD THE SCREW BREAK WHEN IT WAS BEING INSERTER IN THE BONE HOLE.
Patient problems: Insufficient Information
MAUDE report 15657363 ↗MalfunctionNov 2, 2021Crack
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8825BC SUTURE ANCHOR CRACKED UPON INSERTION. THIS WAS DISCOVERED DURING USE IN AN UNSPECIFIED PROCEDURE. THE CASE WAS COMPLETED WITH A NEW AR-8825BC.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12737947 ↗MalfunctionSep 14, 2021Break
ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AR-8825BC MINI PUSHLOCK SUTURE ANCHOR X 2 BROKE DURING INSERTION USING THE SMALL DRILL BIT. ALL BROKEN PIECES WERE REMOVED. THIS WAS DISCOVERED DURING USE IN AN OCP PROCEDURE ON (B)(6)2021. THE CASE WAS COMPLETED USING THE BIG DRILL BIT AND 3 ADDITIONAL AR-8825BC WITHOUT FURTHER ISSUE.
Patient problems: Insufficient Information
MAUDE report 12467141 ↗
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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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