Arthrex® AR-8927DSCRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867131538), received between Oct 11, 2022 and Oct 23, 2025 — classified as 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ON 10/16/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8927DSC CORKSCREW FT, DISP HANDLE TAP CAME APART. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369079 ↗
• MalfunctionMar 18, 2025Material Fragmentation; Physical Resistance/Sticking; Material Fragmentation; Physical Resistance/Sticking

  ON 03/03/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8927DSC DISPOSABLES KIT DRILL BIT WAS CONTACTING THE GUIDE AND CREATING DEBRIS. THE DRILL BIT WAS STUCK TO THE GUIDE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS REMOVED. THE DELAY TO CASE WAS 2 MINUTES. CASE WAS COMPLETED USING ANOTHER KIT OF SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632987 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DRILL GUIDE AR-8927DSC, BROKE WHILE DRILLING. DRILL GUIDE IS STUCK IN DRILL. THE CASE WAS COMPLETED BY USING ANOTHER DRILL WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547156 ↗
• MalfunctionMay 22, 2024Use of Device Problem; Use of Device Problem

  ON 09/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8927DSC DISPOSABLES KITS BLUE TAP HANDLE CAME LOOSE WHILE TAPPING A HOLE FROM THE 4.5 CORKSCREW KIT. TAP HAD TO BE REMOVED WITH PLIERS SINCE HANDLE WAS SPINNING AND NO LONGER FUNCTIONAL. THIS OCCURRED DURING A DISTAL BICEPS PROCEDURE ON (B)(6) 2022. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369771 ↗
• MalfunctionMay 16, 2024Melted; Melted

  ON 12/02/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8927DSC 4.5X14MM CORKSCREW FT, DISPOSABLES KIT GOT DAMAGED. THE DRILL GUIDE FUSED INTO THE DRILL AND DAMAGED THE REST OF THE PRODUCTS IN THE KIT. THE PLASTIC MELTED. ANOTHER KIT WITH A DIFFERENT LOT NUMBER WAS USED AND IT WORKED FINE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330221 ↗
• MalfunctionMay 14, 2024Break; Break

  ON 7/15/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8927DSC FELL APART DURING A QUAD TENDON REPAIR PROCEDURE. UPON TAPPING THE PATELLA AFTER DRILLING FOR THE BIOCOMPOSITE 4.5 CORKSCREW, THE BLUE HANDLE ATTACHED TO THE METAL TAP BEGAN TO SPIN AROUND THE ACTUAL TAP. THIS MADE THE DEVICE HARD TO ADVANCE FORWARD AND BACKWARD. THE BLUE HANDLE WAS PULLED OFF THE METAL TAP - AS ITS ADHERENCE TO EACH OTHER WAS NO LONGER - AND ATTACHED A T-HANDLE CHUCK TO REMOVE THE TAP FROM THE BONE. THEY KEPT THE T-HANDLE CHUCK ON AND USED IT FOR THE OTHER CORKSCREW AS WELL. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19313007 ↗
• MalfunctionOct 6, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 9/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8927DSC 4.5X14MM CORKSCREW FT HAD AN ISSUE. THE BLUE DRILL GUIDE WAS PLACED ONTO THE BONE, AND THE DRILL WAS INSERTED ON FORWARD POWER TO BEGIN DRILLING THE TUNNEL. AS THE DRILL WENT DOWN THE GUIDE, IT PROGRESSED ABOUT 8MM BEFORE THE DRILL HUB STARTED TO GET CAUGHT ON THE GUIDE. AT THIS POINT, THE DRILL WAS STUCK SPINNING IN THE GUIDE, CAUSING METAL SHAVINGS TO DISPERSE. AFTER ABORTING THE ATTEMPT TO DRILL, THE DRILL WAS STUCK IN THE GUIDE AND COULD NOT BE USED. A NEW DISPOSABLE KIT WAS OPENED AND WORKED GREAT. IT WASN¿T UNTIL AFTER THE NEW DRILL WAS USED THAT THEY WERE ABLE TO FREE THE ORIGINAL DRILL OUT OF THE DRILL GUIDE. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/14/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A PERONEAL TENDON REPAIR PROCEDURE. SHAVINGS WERE DISPERSED INSIDE THE PATIENT BUT RETRIEVED. NOTHING BROKE OFF INSIDE THE PATIENT, ONLY SHAVINGS. ALL SHAVINGS WERE RETRIEVED. THERE WAS NO ADVERSE EFFECT, ONLY A SHORT DELAY WHILE A NEW KIT WAS OPENED. THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890292 ↗
• MalfunctionOct 11, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8927DSC CORKSCREW DISPOSABLES KITS TISSUE PROTECTOR BROKE INTO PIECES UPON DRILLING. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE. "WHEN USING THE DRILL GUIDE TO PREP THE BONE, THE BLUE TISSUE PROTECTOR IMMEDIATELY BROKE INTO A FEW PIECES AS THE DRILL BEGAN ROTATING. THE METAL PORTION ON THE INSIDE OF THE TISSUE PROTECTOR WAS LODGED ON THE DRILL."

  Patient problems: Insufficient Information

  MAUDE report 15577581 ↗