Arthrex® AR-8825BRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867046641), received between Dec 15, 2023 and Dec 23, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Break; Break

  ON 12/04/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8825B MINI BIO-PUSHLOCK'S ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A TFCC PROCEDURE WITH NO PATIENT HARM. THE CASE WAS COMPLETED WITH ANOTHER ANCHOR. THE PATIENT¿S BONE QUALITY WAS GOOD, AND NO FRAGMENTS REMAINED IN THE PATIENT. ADDITIONAL INFORMATION PROVIDED 11-DEC-2025: IT WAS FURTHER REPORTED THAT THE CASE WAS COMPLETED WITH A NEW ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881700 ↗
• MalfunctionAug 1, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-8825B, SUTURE ANCHOR, MINI BIO-PUSHLOCK¿ 2.5 MM X 8 MM, WHEN THE SURGEON INSERTED THE ANCHOR, THE SCREW BROKE OFF EASILY AND THE EYELET FELL OUT EASILY. THIS WAS DETECTED DURING A TFCC REPAIR ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER AR-8825B. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION: THERE WAS A DELAY OF ABOUT 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690000 ↗
• MalfunctionJul 17, 2025Break; Break

  ON 24TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-8825B, SUTURE ANCHOR, MINI BIO-PUSHLOCK¿ 2.5 MM X 8 MM, THE ANCHOR'S TIP WAS BROKEN DURING INSERTION. THIS WAS DETECTED DURING A TFCC REPAIR PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER AR-8825B. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION: BEFORE INSERTING THE ANCHOR, THE SURGEON SUSPECTED THAT THE ANCHOR TIP WAS LOOSELY ATTACHED TO THE METAL PART. THERE WAS A DELAY OF ABOUT 10 MINUTES FOR THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22535248 ↗
• MalfunctionMay 9, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED ON 5/13/2025: THE ANCHOR TIP BENT, BUT NOTHING BROKE IN THE PATIENT. THE CASE WAS DELAYED FIVE MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 21996010 ↗
• MalfunctionAug 8, 2024Break; Break

  ON 7/26/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8825B MINI BIO-PUSHLOCK EYELET CAME OFF THE INSERTER. THE CASE WAS COMPLETED USING A NEW AR-8825B MINI BIO-PUSHLOCK. THIS WAS DISCOVERED DURING A TFCC REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED, AND THE PATIENT SUFFERED NO HARM. ADDITIONAL INFORMATION RECEIVED ON 8/1/2024: PUSHLOCK EYELET BROKE OFF IN THE PATIENT AND IT WAS SUCCESSFULLY RETRIEVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937791 ↗
• MalfunctionFeb 1, 2024Break; Break

  ON 01/11/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8825B 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 18624535 ↗
• MalfunctionFeb 1, 2024Break; Break

  ON 01/11/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8825B 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 18624517 ↗
• MalfunctionJan 25, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 01/02/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8825B SUTURE ANCHOR WOULD NOT SEPERATE FROM THE SCREW ONCE INSERTED. THE CASE WAS COMPLETED USING ANOTHER AR-8825B WITH UNKNOWN LOT NUMBERS.

  Patient problems: Insufficient Information

  MAUDE report 18581148 ↗
• MalfunctionDec 15, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A HAND SURGERY THE ANCHOR COULD NOT BE DETACHED FROM THE DRIVER. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340857 ↗