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Arthrex® AR-8741-40Recalls & reported problems

Arthrex, Inc. · Driver, T10 Hexalobe, Beveled FT · Class 1

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

Quick summary

This Arthrex surgical driver is a handheld tool used to insert screws during orthopedic operations. The 86 reports, with no deaths and no injuries, mostly describe the driver breaking or coming apart during surgery, sometimes leaving metal fragments that had to be retrieved from the patient. No recalls name this device. Reports fell from 38 to 18 over the past 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
86
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00888867362635), received between Jun 6, 2022 and Aug 28, 2026 — classified as 86 malfunctions.

The most frequently reported specific device problem is “Break” (84 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: 1 reportsDec 2023: 1 reportsJan 2024: 1 reportsFeb 2024: 2 reportsMar 2024: 3 reportsApr 2024: 5 reportsMay 2024: 2 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 4 reportsMar 2025: 2 reportsApr 2025: 6 reportsMay 2025: 9 reportsJun 2025: 2 reportsJul 2025: 0 reportsAug 2025: 7 reportsSep 2025: 2 reportsOct 2025: 4 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 3 reportsFeb 2026: 7 reportsMar 2026: 3 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520269
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break84
  • Failure to Advance1
  • Material Fragmentation1
  • Physical Resistance/Sticking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions69
  • Insufficient Information16
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
  • Foreign Body In Patient2

Recent adverse event reports

The 25 most recent of 86 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 50502720 ↗
  • MalfunctionApr 30, 2026Break

    ON 13-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8741-40 DRIVER IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS WERE RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25043823 ↗
  • MalfunctionApr 30, 2026Break

    ON 13-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8741-40 DRIVER IS BROKEN. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ALL FRAGMENTS WERE RETRIEVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25043816 ↗
  • MalfunctionMar 26, 2026Break

    ON (B)(6) 2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT QTY 2 AR-8741-40 T-10 DRIVERS BROKE WHILE INSERTING AN AR-8735BV-40 BEVELED FT SCREW. FRAGMENTS WERE PRODUCED, AND ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE CASE WAS ABLE TO BE COMPLETED SUCCESSFULLY. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24697458 ↗
  • MalfunctionMar 26, 2026Break

    ON 5-MAR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT QTY 2 AR-8741-40 T-10 DRIVERS BROKE WHILE INSERTING AN AR-8735BV-40 BEVELED FT SCREW. FRAGMENTS WERE PRODUCED, AND ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE CASE WAS ABLE TO BE COMPLETED SUCCESSFULLY. NOTICED DURING A CASE WITH NO PATIENT EFFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24697372 ↗
  • MalfunctionMar 20, 2026Break

    ON 02-MAR-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8741-40 T10 BEVELED HEXALOBE DRIVER SHAFT BROKE OFF INTO THE HEAD OF THE SCREW WHEN INSERTING INTO PATIENT DURING A METACARPAL FX PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAR-2026. THE REP ADVISED THAT THE SURGEON USED A HANDLE (AR-8700RH) ATTACHED TO THE DRIVER SHAFT (AR-8741-40) TO INSERT THE SCREW BY HAND. THEY STATED THE SURGEON USED A 1.4MM GUIDE WIRE (AR-8741-14), AS WELL AS A 2.9MM DRILL BIT (AR-8741-25) TO PREP THE BONE FOR THE INSERTION OF THE SCREW. THE SURGEON WAS NOT ABLE TO USE THE DRIVER SHAFT (AR-8741-40) TO REMOVE THE SCREW SINCE THE DRIVER SHAFT BROKE OFF INTO THE HEAD OF THE SCREW (AR-8735BV-50). THEY WERE ABLE TO USE INSTRUMENTS THE HOSPITAL OWNED TO RETRIEVE THE REMAINING PIECES OF THE DRIVER SHAFT OUT OF THE HEAD OF THE SCREW. THEY THEN USED A DIFFERENT DRIVER SHAFT TO REMOVE THE SCREW (AR-8735BV-50), THEY RE-DRILLED WITH AN AR-8741-25, AND INSERTED AN AR-8735BV-48, WHICH WAS IMPLANTED USING A DIFFERENT DRIVER SHAFT. THE SURGEON USED THE 3.5MM BEVELED SCREWS, IMPLANTED/EXPLANTED AR-8735BV-

    Patient problems: Insufficient Information

    MAUDE report 24650044 ↗
  • MalfunctionFeb 24, 2026Break

    ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8741-40 DRIVER, T10 HEXALOBE, BEVELED FT FELL APART. THIS ISSUE WAS DISCOVERED DURING A CASE WITH PATIENT AFFECT.

    Patient problems: Foreign Body In Patient

    MAUDE report 24429277 ↗
  • MalfunctionFeb 20, 2026Break; Material Fragmentation

    ON 04-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8741-40 BEVELED FT T10 HEXALOBE DRIVER FRAGMENTED UPON INSERTION OF THE BEVELED SCREW, THE FRAGMENTS WERE WEDGED IN THE SCREW AND SOFT TISSUE AND THE FRAGMENTS WERE RETRIEVED. ANOTHER DRIVER WAS USED TO FINISH THE INSERTION, BUT IT IMPACTED THE DEGREE OF FIXATION WITH A DELAY OF 40 MINUTES TO THE CASE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24400057 ↗
  • MalfunctionFeb 18, 2026Break

    IT WAS REPORTED THAT DURING THE MINIMAL INCISION SURGERY OF THE FEET, A PART OF THE TIP OF THE DRIVER BROKE OFF. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. 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 24375899 ↗
  • MalfunctionFeb 12, 2026Break

    IT WAS REPORTED THAT DURING THE MINIMALLY INVASIVE CHEVRON AND AKIN OSTEOTOMY, THE TIP OF THE DRIVER BROKE OFF WHEN IT WAS USED TO INSERT A SCREW. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. 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 24321912 ↗
  • MalfunctionFeb 11, 2026Break

    ON 23-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8741-40 DRIVER BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO BROKEN FRAGMENTS LEFT INSIDE THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24315115 ↗
  • MalfunctionFeb 4, 2026Break

    IT WAS REPORTED THAT DURING THE SCREW REMOVAL SURGERY, THE DEVICE BROKE WHILE ATTEMPTING TO REMOVE 3.5 MM BEVELED SCREWS. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. 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 24257399 ↗
  • MalfunctionFeb 4, 2026Break

    IT WAS REPORTED THAT DURING THE SCREW REMOVAL SURGERY, THE DEVICE BROKE WHILE ATTEMPTING TO REMOVE 3.5 MM BEVELED SCREWS. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. 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 24257397 ↗
  • MalfunctionJan 26, 2026Break

    ON (B)(6) 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8741-40 DRIVER BROKE WHILE INSERTING A BEVELED SCREW. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24179186 ↗
  • MalfunctionJan 26, 2026Break

    ON 29-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8741-40 DRIVER BROKE WHILE INSERTING A BEVELED SCREW. NOTICED DURING A CASE, DEVICE SWAPPED, AND CASE COMPLETED WITH NO PATIENT EFFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24179182 ↗
  • MalfunctionJan 16, 2026Break

    IT WAS REPORTED THAT DURING A SURGERY THE SCREWDRIVER BROKE. 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 24092265 ↗
  • MalfunctionDec 23, 2025Break; Break

    ON 12/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8741-40 DRIVER T10 HEXALOBE BROKE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23878877 ↗
  • MalfunctionDec 8, 2025Break; Break

    IT WAS REPORTED DURING THE MINIMALLY INVASIVE CHEVRON AND AKIN OSTEOTOMY THAT THE DRIVER BROKE OFF WHEN INSERTING THE SCREW. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. 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 23741841 ↗
  • MalfunctionOct 29, 2025Break; Break

    ON 10/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8741-40 T10 DRIVER SHAFT BROKE OFF IN A BEVELED FT SCREW. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23416026 ↗
  • MalfunctionOct 27, 2025Break; Break

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE CHEVRON AKIN SURGERY THE SCREWDRIVER BROKE WHILE INSERTING THE SCREW. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE BECAUSE THE FAILURE OCCURRED IN THE END OF THE INSERTION. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23391755 ↗
  • MalfunctionOct 27, 2025Break; Break

    ON 10/20/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8741-40 DRIVER, T10 HEXALOBE TIP BROKE. THIS WAS DISCOVERED DURING THE CASE. DEBRIS WAS PRODUCED BUT THE BROKEN PIECE WAS RETRIEVED WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23390882 ↗
  • MalfunctionOct 27, 2025Break; Break

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE CHEVRON AKIN (MICA) SURGERY THE SCREW DRIVER BROKE WHILE INSERTING SCREW. THEY REMOVED EVERY PIECE OF DAMAGED INSTRUMENT. 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 23390314 ↗
  • MalfunctionSep 15, 2025Break; Break

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE CHEVRON AND AKIN (MICA) SURGERY THE DEVICES AR-8741-40 (LOT: 4580407) BROKE WHILE EXTRACTING THE SCREWS. THE SURGEON EASILY REMOVED EVERY PIECE OF THE DAMAGED INSTRUMENTS. 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 23051608 ↗
  • MalfunctionSep 15, 2025Break; Break

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE CHEVRON AND AKIN (MICA) SURGERY THE DEVICES AR-8741-40 (LOT: 4580407) BROKE WHILE EXTRACTING THE SCREWS. THE SURGEON EASILY REMOVED EVERY PIECE OF THE DAMAGED INSTRUMENTS. 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 23051600 ↗
  • MalfunctionAug 25, 2025Break; Break

    ON 08/07/2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-07012596 THAT AN AR-8741-40 3.5 MM BEVELED FT DRIVER TIP BROKE OFF. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22883038 ↗

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Sources and updates

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