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
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
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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