Arthrex® AR-1250LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867006287), received between Apr 18, 2022 and Aug 6, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50158547 ↗
• MalfunctionAug 8, 2024Break; Break

  ON 24TH JULY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1250LT, STEP DRILL FOR 3.0MM BIO-SUTURETAK®, WAS USED TO PUNCH HOLES INTO THE BONE TO FACILITATE SCREW INSERTION HOWEVER THE DRILL BIT BROKE DURING DRILLING AND ABOUT 15MM OF THE BROKEN DRILL BIT REMAINED IN THE SHOULDER BLADE. THIS WAS DETECTED DURING USE IN A REPAIR OF THE RIGHT SHOULDER JOINT CAPSULE AND LIP SURGERY ON (B)(6) 2019. THERE WAS NO ADVERSE EFFECT ON THE PATIENT'S ORIGINAL CONDITION, BUT IT MAY NOT BE POSSIBLE TO PERFORM MAGNETIC RESONANCE EXAMINATION IN THE FUTURE. IT WAS REPORTED TO NMPA AS ADVERSE EVENTS BY HOSPITAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ONLY ISSUE BEING THAT THE BROKEN PIECE WAS LEFT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19943932 ↗
• MalfunctionJul 11, 2024Break; Break

  ON 06/28/2024 ADDITIONAL INFORMATION WAS PROVIDED BY THE ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL WHO STATED THAT THE PROCEDURE BEING PERFORMED WAS A PATELLOFEMORAL. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE HOSPITALS 2.0 GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE.

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

  MAUDE report 19721053 ↗
• MalfunctionMar 5, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 02/19/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1250LT STEP DRILL GOT STUCK IN THE DRILL GUIDE WHEN MAKING THE PRE-HOLE. THIS OCCURRED DURING A CASE WHERE ANOTHER AR-1250LT WAS USED TO COMPLETE THE CASE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838913 ↗
• MalfunctionMar 1, 2024Break; Break

  ON 02/15/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1250LT STEP DRILL FOR 3.0MM BIO-SUTURETAK BROKE AND GOT STUCK IN THE PATIENT'S BONE. THE BROKEN FRAGMENTS WERE NOT RETRIEVED AND REMAIN IN THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18818191 ↗
• MalfunctionSep 26, 2023Break; Break

  ON 8/28/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06016980 THAT AN AR-1250LT STEP DRILL BROKE DURING A BROSTROM PROCEDURE ON (B)(6) 2023. THE BONE TUNNEL WAS COMPLETED BEFORE THE DRILL BROKE. THE BROKEN PART WAS RECOVERED, AND THERE WAS NO HARM TO THE PATIENT. IT WAS POSSIBLE TO INSERT THE ANCHOR, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DRILL FRAGMENTS WERE DISPOSED OF AT THE HOSPITAL. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2023, THE ARTHREX SUBSIDIARY EMPLOYEE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THERE WAS NO CASE DELAY REPORTED. THIS EVENT WAS NOT AN ADVERSE REPORTABLE EVENT AND DID NOT MEET THE REPORTABILITY REQUIREMENTS OF ARTICLE 8 OF RDC 67/2009.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816964 ↗
• MalfunctionApr 18, 2022Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE DRILL BROKE OFF AT THE BACK PART AND INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. 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 14135454 ↗