Arthrex® AR-8825PRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867046672), received between Jul 15, 2020 and Oct 16, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionOct 16, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT TWO AR-8825P PEEKS MINI PUSHLOCK ANCHORS MALFUNCTIONED. THE THREADED PORTION OF THE ANCHOR FAILED TO ENTER THE DRILL HOLE, DESPITE BEING IMPACTED ACCORDING TO THE ESTABLISHED TECHNIQUE. AS A RESULT, THE TIP OF THE FIRST ANCHOR FRACTURED, PREVENTING ADEQUATE FIXATION AT THE SURGICAL SITE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE PERFORMED ON (B)(6) 2025.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312729 ↗
• MalfunctionOct 16, 2025Failure to Advance; Failure to Advance

  ON 10/13/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT TWO AR-8825P PEEK MINI PUSHLOCK ANCHORS MALFUNCTIONED. THE THREADED PORTION OF THE ANCHOR FAILED TO ENTER THE DRILL HOLE, DESPITE BEING IMPACTED ACCORDING TO THE ESTABLISHED TECHNIQUE. AS A RESULT, THE TIP OF THE FIRST ANCHOR FRACTURED, PREVENTING ADEQUATE FIXATION AT THE SURGICAL SITE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE PERFORMED ON (B)(6) 2025.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23312627 ↗
• MalfunctionDec 12, 2024Break; Break

  ON 14TH NOVEMBER 2024, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8825P SUTURE ANCHOR, PEEK MINI PUSHLOCK® 2.5 MM X 8 MM, BROKE DURING THE SURGERY. THIS WAS DISCOVERED DURING USE IN AN ARTHROSCOPIC RECONSTRUCTION OF CARPAL TRIANGLE CARTILAGE INSERTION PROCEDURE ON 6TH NOVEMBER 2024 WITH NO PATIENT HARM. THE PROCEDURE COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-8825P. ALL THE FRAGMENTS WERE RETRIEVED FROM THE PATIENT. NO SECONDARY PROCEDURE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916999 ↗
• MalfunctionJun 14, 2024Break; Break

  ON 2/24/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8825P PEEK MINI PUSHLOCK METAL PIECE AT THE HANDLE END WAS BROKEN AND THE ANCHOR COULD NOT BE MALLET IN. THIS WAS DISCOVERED DURING A THUMB MCP PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19542941 ↗
• MalfunctionMay 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 04/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8825P SUTURE ANCHORS EYELET KEPT COMING OFF. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 19220732 ↗
• MalfunctionJan 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 12/29/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT DURING A PROCEDURE ON (B)(6) 2023, WHEN PASSING THE 2-0 FIBERWIRE SUTURES THROUGH THE EYELET OF THE MINI PEEK SUTURE ANCHOR, AR-8825P, THEY TEND TO COME OUT OF THE EYELET, PREVENTING THEIR USE AND HAVING TO BE REPLACED WITH ANOTHER IMPLANT. THIS OCCURRED DURING A TRIANGULAR FIBROCARTILAGE COMPLEX (TFCC) PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552359 ↗
• MalfunctionAug 25, 2023Break; Break

  ON 7/28/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8825P PEEK MINI PUSHLOCK TIP WAS DAMAGED DURING INSERTION. THIS WAS DISCOVERED DURING A WRIST ARTHROSCOPY PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED WITH ANOTHER IMPLANT. ADDITIONAL INFORMATION RECEIVED ON 7/31/2023: THE TIP PARTIALLY BROKE DURING INSERTION; HOWEVER, THERE WERE NO LOOSE FRAGMENTS INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17623670 ↗
• MalfunctionApr 26, 2023Break; Break

  ON 3/28/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8825P PEEK MINI PUSHLOCK ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 3/31/2023: THIS WAS DISCOVERED DURING AN INTERNAL INTERCARPAL BRACE PROCEDURE AND WAS COMPLETED USING ANOTHER AR-8825P PEEK MINI PUSHLOCK. ALL OF THE BROKEN FRAGMENTS WERE RETRIEVED FROM INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814952 ↗
• InjuryJul 15, 2020Unstable; Noise, Audible

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A TFFCC REPAIR ON (B)(6) 2018 HAS STARTED TO SUFFER PAIN IN HER LITTLE AND RING FINGER. DURING THE SURGERY A ARTHREX PUSHLOCK SYSTEM WAS IMPLANTED INTO THE PATIENTS LEFT WRIST. THE SURGEON SUGGESTED THAT THE WRIST IS "UNSTABLE" DURING A FOLLOW UP VISIT AT THE HOSPITAL. IN ADDITION TO THE PAINT THE PATIENT ALSO EXPERIENCED CREAKING AND GRINDING NOISES AND BOTH FINGERS ARE INCREDIBLY SORE AND THE WRIST/HAND GENERALLY ACHES. NO FURTHER INFORMATION ARE CURRENTLY AVAILABLE AND NO X-RAY OR MRI WAS PERFORMED.

  Patient problems: Pain

  MAUDE report 10279615 ↗