Arthrex® AR-1204DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867004450), received between Aug 17, 2022 and Mar 10, 2026 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Dull, Blunt

  IT WAS REPORTED THAT DURING A SURGERY, THE DRILL WAS BLUNT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION WAS RECEIVED. UPDATE 09-MAR-2026 - FURTHER INFORMATION WAS RECEIVED: IT WAS REPORTED THAT DURING THE LATARJET SURGERY, THE DRILL WAS BLUNT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559136 ↗
• MalfunctionMay 30, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A LATARJET SURGERY WITH CORACOID BONEBLOCK THE DRILLS WERE BLUNT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE, KHE, 30-MAY2025 THE DEVICE WAS PART OF THE LOAN SET DLS-GBL-IN-10145474.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118645 ↗
• MalfunctionMay 30, 2025Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING A LATARJET SURGERY WITH CORACOID BONEBLOCK THE DRILLS WERE BLUNT. PER COMPLAINT REPORTER 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, KHE, 30-MAY2025 THE DEVICE WAS PART OF THE LOAN SET DLS-GBL-IN-10145513.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117836 ↗
• MalfunctionOct 8, 2024Break; Break

  ON 09/27/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1204D BIO-TENODESIS¿ SCREW DRILL BROKE. THIS OCCURRED DURING A CASE THERE WAS NO DAMAGE TO THE PATIENT AND NO RESIDUE WAS LEFT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397604 ↗
• MalfunctionSep 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A LATARJET SURGERY THE DRILL BROKE OFF DURING THE DRILLING PROCESS. THE FRAGMENT REMAINED INSIDE THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20320551 ↗
• MalfunctionApr 15, 2024Material Fragmentation; Material Fragmentation

  ON 3/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1204D BIO-TENODESIS SCREW DRILL, 4.0 MM (FROM A LOANER SET RAR-7000S UNDER ORDER (B)(4) WAS NOT PROPERLY FITTED THROUGH EITHER CORACOID DRILL GUIDE GUIDE AR-7000-17 OR AR-7000-07. IT APPEARED THERE WAS A DEFECT IN THE DRILL AR-1204D, CAUSING METAL SHAVINGS TO SPEW OUT OF THE DRILL GUIDE. NO DRILL PIECES BROKE INSIDE THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A LATARJET PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 3/25/2024: IT APPEARED THE METAL SHAVINGS WERE COMING OFF OF THE GUIDE, BUT NEITHER THE GUIDE NOR THE DRILL BROKE. THE CASE WAS COMPLETED USING AN AR-1204D BIO-TENODESIS SCREW DRILL. THERE WAS NO REPORT OF ADVERSE EFFECTS ON THE PATIENT OR DELAY IN THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105655 ↗
• MalfunctionJan 4, 2024Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-1204D DRILL BIT BROKE WHEN DRILLING THE HOLE IN THE GRAFT, WITH NO IMPACT ON THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445621 ↗
• MalfunctionNov 16, 2022Break; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE DRILL WAS SLIGHTLY BENT AND BROKE OFF DURING A LATARJET SURGERY. THE DRILL BROKE OFF, BUT ALL BROKEN PARTS WERE RETRIEVED FROM PATIENT. APPARENTLY, THE INSTRUMENT WAS DELIVERED BENT. 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 15804006 ↗
• MalfunctionAug 17, 2022Material Fragmentation; Overheating of Device

  IT WAS REPORTED THAT A 4.0MM DRILL WAS USED FOR A LATARJET SURGERY. THIS GOT STUCK IN THE CORACOID DRILL GUIDE (AR-7000-17). ACCORDING TO THE SURGEON IT WOULD NOT PASS THROUGH THE GUIDE AT ALL. AS SUCH IT WAS CAUSING A LOT OF HEAT AND ALSO CAUSED SOME MINOR METAL FRAGMENTS TO BUILD UP AROUND THE GUIDE, A SMALL AMOUNT ENTERED THE PATIENT BUT WERE WASHED OUT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A 3.5 MM DRILL INSTEAD OF A 4.0MM DRILL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242810 ↗