Arthrex® AR-8741-40SRecalls & reported problems
Arthrex, Inc. · Driver, T10 Hexalobe, Short, Beveled FT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867362642), received between Oct 24, 2023 and Aug 28, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Break” (11 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break11
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Foreign Body In Patient1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503238 ↗MalfunctionDec 2, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED DURING THE SCREW EXTRACTION SURGERY THAT THE DRIVER TWISTED WHEN UNSCREWING A SCREW. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696587 ↗MalfunctionMay 27, 2025Break; Break
IT WAS REPORTED THAT DURING A MICA SURGERY THE TIP OF THE DRIVER BROKE OFF. THE X-RAY SHOWS THAT A PIECE OF THE TIP REMAINS INSIDE THE PATIENT, A REVISION SURGERY IS NOT PLANNED. 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.
Patient problems: Foreign Body In Patient
MAUDE report 22087963 ↗MalfunctionMay 6, 2025Break; Break
ON 04/21/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8741-40S DRIVER AND AN AR-8741-40 DRIVER BOTH BROKE WHEN ATTEMPTED TO ADVANCE A BEVELED SCREW. ALL BROKEN PIECES WERE REMOVED. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21966920 ↗MalfunctionAug 26, 2024Break; Break
ON 07/09/2024, A SALES REPRESENTATIVE VIA SEMS- (B)(4) REPORTED THAT (QTY. 2) OF AN AR-8741-40S 3.5 MM BEVELED FT DRIVER BROKE DURING THE CASE WHEN TRYING TO GET A SCREW OUT, AND THE HEAD OF THE DRIVER BROKE OFF ON BOTH. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 7/15/2024: (B)(4) AN AR-8741-40S 3.5 MM BEVELED FT DRIVER BROKE INSIDE THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO CASE DELAY. THERE WERE NO REPORTED ISSUES WITH THE SCREW ITSELF. THIS WAS DISCOVERED DURING A METACARPAL FRACTURE PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING A SOLID T10 DRIVER WAS USED TO BACK OUT THE SCREW. A NEW HOLE WAS DRILLED, AND A NEW SCREW WAS PUT IN. THE PATIENT HAS NOT EXPERIENCED ADVERSE EFFECTS DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20064495 ↗MalfunctionJul 22, 2024Break; Break
ON 07/09/2024, A SALES REPRESENTATIVE VIA SEMS- (B)(4) REPORTED THAT (QTY. 2) OF AN AR-8741-40S 3.5 MM BEVELED FT DRIVER BROKE DURING THE CASE WHEN TRYING TO GET A SCREW OUT, AND THE HEAD OF THE DRIVER BROKE OFF ON BOTH. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 7/15/2024: (QTY. 2) AN AR-8741-40S 3.5 MM BEVELED FT DRIVER BROKE INSIDE THE PATIENT, AND ALL FRAGMENTS WERE RETRIEVED. THERE WAS NO CASE DELAY. THERE WERE NO REPORTED ISSUES WITH THE SCREW ITSELF. THIS WAS DISCOVERED DURING A METACARPAL FRACTURE PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING A SOLID T10 DRIVER WAS USED TO BACK OUT THE SCREW. A NEW HOLE WAS DRILLED, AND A NEW SCREW WAS PUT IN. THE PATIENT HAS NOT EXPERIENCED ADVERSE EFFECTS DUE TO THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19793774 ↗MalfunctionJul 16, 2024Break; Break
IT WAS REPORTED THAT DURING A REMOVAL OF METALWORK THE TIP OF THE DEVICE BROKE WHILE REMOVING A 3.5 COMP FT SCREW. ALL PARTS WERE RETRIEVED FROM THE PATIENT. 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 19749058 ↗MalfunctionJul 16, 2024Break; Break
IT WAS REPORTED THAT DURING A REMOVAL OF METALWORK THE TIP OF THE DEVICE BROKE WHILE REMOVING A 3.5 COMP FT SCREW. ALL PARTS WERE RETRIEVED FROM THE PATIENT. 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 19748996 ↗MalfunctionJun 5, 2024Break; Break
IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE FOOT SURGERY THE DEVICE BROKE BEFORE THE INSERTION IN THE PATIENT. 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 17-JAN-2023 NEN: FURTHER INFORMATION REVEALED THAT 4MM OF THE SCREWDRIVER TIP BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19472929 ↗MalfunctionMar 14, 2024Break; Break
ON 3/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8741-40 DRIVER AND (2) AR-8741-40S DRIVER BROKE DURING USE WITH NO PIECES BREAKING OFF INSIDE THE PATIENT REPORTED. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING A METACARPAL FX PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 3/7/2024: THE DRIVERS BROKE AS THE SURGEON WAS ATTEMPTING TO GET THE FINAL FIXATION FOR A METACARPAL FRACTURE. ONE OF THE DRIVERS BROKE IN THE PATIENT, TAKING 15 MINUTES TO RETRIEVE IT. THE OTHER THREE DRIVERS ONLY CRACKED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. A FOURTH DRIVER WAS USED TO COMPLETE THE PROCEDURE. THEY REMOVED THE SCREW, DRILLED AGAIN (CYCLING THE DRILL), AND THEN PUT THE SCREW BACK IN. THE DRIVER DIDN¿T CRACK, BUT THE THREADS WERE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 3/8/2024: PER THE SALES REP ON PHOTO ATTACHMENT "ONE OF THE AR-8741-40S¿ BROKE IN PATIENT WHOLE SURGEON WAS ADVANCING THE SCREW AND SURGEON HAD TO FISH FRAGMENTS OUT. THE OTHER SHORT DRIVER BROKE BUT DID NOT FULLY DISCONNECT FROM THE DRIVER. SAME FOR THE ONE LONG DRIVER. THE FOURTH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18905297 ↗MalfunctionMar 14, 2024Break; Break
ON 3/5/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-8741-40 DRIVER AND (2) AR-8741-40S DRIVER BROKE DURING USE WITH NO PIECES BREAKING OFF INSIDE THE PATIENT REPORTED. THE CASE WAS COMPLETED SUCCESSFULLY, AND NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING A METACARPAL FX PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 3/7/2024: THE DRIVERS BROKE AS THE SURGEON WAS ATTEMPTING TO GET THE FINAL FIXATION FOR A METACARPAL FRACTURE. ONE OF THE DRIVERS BROKE IN THE PATIENT, TAKING 15 MINUTES TO RETRIEVE IT. THE OTHER THREE DRIVERS ONLY CRACKED. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. A FOURTH DRIVER WAS USED TO COMPLETE THE PROCEDURE. THEY REMOVED THE SCREW, DRILLED AGAIN (CYCLING THE DRILL), AND THEN PUT THE SCREW BACK IN. THE DRIVER DIDN¿T CRACK, BUT THE THREADS WERE DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED ON 3/8/2024: PER THE SALES REP ON PHOTO ATTACHMENT "ONE OF THE AR-8741-40S¿ BROKE IN PATIENT WHOLE SURGEON WAS ADVANCING THE SCREW AND SURGEON HAD TO FISH FRAGMENTS OUT. THE OTHER SHORT DRIVER BROKE BUT DID NOT FULLY DISCONNECT FROM THE DRIVER. SAME FOR THE ONE LONG DRIVER. THE FOURTH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18905261 ↗MalfunctionOct 24, 2023Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE DRIVER BROKE. THE BREAKAGE POINT WAS OUTSIDE OF THE PATIENT AND NOTHING HAD TO BE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17995103 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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