Skip to content

Arthrex® AR-1934D-24Recalls & reported problems

Arthrex, Inc. · STEP DRILL, 2.4MM, BIO-SUTURETAK · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867024045), received between Nov 29, 2016 and Feb 27, 2026 — classified as 1 injury, 4 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break4
  • Detachment Of Device Component1
  • Material Twisted/Bent1

Patient problems

  • Foreign Body In Patient2
  • No Clinical Signs, Symptoms or Conditions2
  • Insufficient Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 27, 2026Break

    ON 09-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-1934D-24 STEP DRILLS BROKE. THE SURGEON HAD THE TIP OF THE DRILL BIT BREAK OFF AT THE STEPPED SECTION. HE WAS NOT TORQUING THE DRILL, AND IT WAS RUNNING AT FULL SPEED FORWARD. DESPITE WHAT APPEARED TO BE PROPER TECHNIQUE, BOTH DRILLS STILL BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24474728 ↗
  • MalfunctionFeb 27, 2026Break

    ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-1934D-24 STEP DRILLS BROKE. THE SURGEON HAD THE TIP OF THE DRILL BIT BREAK OFF AT THE STEPPED SECTION. HE WAS NOT TORQUING THE DRILL, AND IT WAS RUNNING AT FULL SPEED FORWARD. DESPITE WHAT APPEARED TO BE PROPER TECHNIQUE, BOTH DRILLS STILL BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24473644 ↗
  • MalfunctionMar 22, 2024Material Twisted/Bent; Material Twisted/Bent

    ON 3/1/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1934D-24 SUTURETAK DRILL TIP WAS BENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 18959081 ↗
  • MalfunctionDec 22, 2023Break; Break

    ON 12/4/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-06421551 THAT AN AR-1934D-24 DRILL FOR A 2.4 MM SUTURETAK DRILL BIT BROKE INSIDE THE BONE. THE TECHNIQUE WAS CARRIED OUT CORRECTLY, BUT THE PATIENT'S BONE WAS HARD, AND WHEN THE SURGEON PUSHED TOO HARD, IT BROKE. THE TIP REMAINED IMPLANTED IN THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO INFORMATION PROVIDED. THIS WAS DISCOVERED DURING AN ELBOW TRICEPS PROCEDURE ON 11/27/2023.

    Patient problems: Foreign Body In Patient

    MAUDE report 18384993 ↗
  • InjuryNov 29, 2016Break; Detachment Of Device Component

    IT WAS REPORTED VIA A MEDWATCH ((B)(4)) THAT THE DRILL BIT BROKE OFF IN THE BONE AND THAT THE SURGEON LEFT IT IN BECAUSE IT REPORTEDLY WOULD CAUSE MORE HARM TRYING TO RETRIEVE THE BROKEN PIECE THAN LEAVING IT IN. X-RAY PERFORMED ON AREA TO DETERMINE ACTION. IT WAS AN ARTHREX 2.4 SUTURE TAK DRILL BIT, AR-1934D-24. REPORT STATES THEY ARE AWARE OF NO PATIENT INJURY AT THE TIME.

    Patient problems: Foreign Body In Patient

    MAUDE report 6132363 ↗

Other BIT, DRILL devices

All BIT, DRILL devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page