Arthrex® AR-8750-03Recalls & reported problems
Arthrex, Inc. · T15 HEXALOBE, ISO, CANN. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex surgical driver is a handheld orthopedic tool used to insert or remove screws. Reports mostly describe the tip breaking or bending during surgery, sometimes during hardware removal, with fragments generally retrieved. There are 29 reports that name its identifier, with no deaths and 2 injuries mentioned. No recalls name this device.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888867263765), received between Apr 13, 2021 and Oct 31, 2025 — classified as 2 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Break” (22 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
- Break22
- Material Twisted/Bent4
- Detachment of Device or Device Component1
- Material Fragmentation1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information7
- Foreign Body In Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED ON 11/4/2025: THIS ISSUE WAS DISCOVERED DURING A HARDWARE REMOVAL PROCEDURE. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438026 ↗MalfunctionMar 17, 2025Material Twisted/Bent; Material Twisted/Bent
ON 02/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT 2 AR-8750-03 HEXALOBE DRIVER SHAFT TIP IS TWISTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO PIECE BROKE OFF INSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21618656 ↗MalfunctionMar 17, 2025Material Twisted/Bent; Material Twisted/Bent
ON 02/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT 2 AR-8750-03 HEXALOBE DRIVER SHAFT TIP IS TWISTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. NO PIECE BROKE OFF INSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21618478 ↗MalfunctionNov 4, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8750-03 DRIVER SHAFT, T15 HEXALOBE, CANNULATED HAD THE TIP OF THE SCREW BREAK OFF IN THE HEAD OF THE SCREW WHEN THE SURGEON WAS TRYING TO BACK OUT THE SCREW. THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO PIECES BREAKING OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20599334 ↗MalfunctionSep 26, 2024Break; Break
ON 09/09/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-12 DRIVER SHAFT ENDED UP GETTING A SCREW STUCK ON IT DURING THE REMOVAL, AND WE COULD NOT REMOVE IT FROM THE DRIVER ITSELF, AND (2) AR-8750-03 DRIVER SHAFTS BROKE DURING THE REMOVAL. THERE WAS NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20309922 ↗MalfunctionSep 16, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A TALONAVICULAR FUSION SURGERY THE DRIVER BROKE DURING NORMAL USE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 AVOE 04-SEP-2024 IT WAS CONFIRMED THAT JUST THE END OF THE DEVICE BENT AND THERE WERE NO FRAGMENTS TO RETRIEVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20225040 ↗MalfunctionJul 15, 2024Break; Break
ON 6/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS- (B)(4) THAT AN AR-8770-01 DRIVER SHAFT (COMPONENT SET OF AR-8750S LOT 15187400) SNAPPED DURING USE AND ALL FRAGMENTS WERE RETRIEVED, AND AN AR-8750-03 DRIVER SHAFT SNAPPED DURING USE AND ALL FRAGMENTS WERE RETRIEVED. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19740238 ↗MalfunctionJun 18, 2024Break; Break
IT WAS REPORTED THAT DURING A TRILLAT SURGERY THE TIP OF THE DRIVER BROKE OFF. THE DEVICE BROKE INSIDE THE PATIENT BUT ALL PARTS WERE RETRIEVED. 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 19562798 ↗MalfunctionMay 17, 2024Break; Break
ON 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8750-03 DRIVER SHAFT TIP BROKE OFF. THIS OCCURRED DURING A PROCEDURE WHERE THE FRAGMENT WAS RETRIEVED. THE DEVICE WAS SWITCHED OUT AND THE CASE COMPLETED.
Patient problems: Insufficient Information
MAUDE report 19345070 ↗MalfunctionApr 26, 2024Break; Break
IT WAS REPORTED THAT DURING A TRILLAT SURGERY WITH 5.0 XLCOMPFT THE TIP OF THE DEVICE BROKE INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19190640 ↗MalfunctionMar 21, 2024Break; Break
ON 3/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8750-03 DRIVER SHAFT BROKE WHILE PUTTING IN A SCREW. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18951532 ↗MalfunctionJan 10, 2024Break; Break
ON 12/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8750-03 HEXALOBE CANNULA BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18486751 ↗MalfunctionAug 30, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8750-03 DRIVER SHAFT BROKE WHILE INSERTING A 5.0 COMPRESSION SCREW AND GOT STUCK INSIDE THE SCREW ITSELF. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. ALL METAL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17652347 ↗MalfunctionAug 29, 2023Break; Break
ON 07/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-8750-03 DRIVER SHAFTS, AND (2) AR-8750-06 DRIVER SHAFTS FAILED TO REMOVE SCREWS. THIS OCCURRED DURING A CASE ON (B)(6) 2023, THE PROPER TECHNIQUE WAS USED HOWEVER THE SURGEON WAS UNABLE TO SUCCESSFULLY REMOVE THE SCREWS WITH THE PROPER EQUIPMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS PROVIDED ON 08/01/2023, IT WAS REPORTED THAT THE DRIVERS ARE TWISTED ON MOST AND THE TIP BROKE OFF OF ONE COMPLETELY, THE REPRESENTATIVE WAS UNSURE OF WHICH DEVICE BROKE. ADDITIONAL INFORMATION WAS PROVIDED ON 08/16/2023, THE DRIVERS FROM THE SET WERE USED IN AN ATTEMPT TO REMOVE THE SCREWS, BUT THEY WERE UNSUCCESSFUL. THEY HAD TO USE A SYNTHES SCREW REMOVAL SET WITH SEVERAL OTHER DRIVERS AND LARGER, DEEPER, TREPHINES TO GET THE SCREWS OUT. ONE OF THE 2 SCREWS BROKE AND ONLY A PORTION OF THE SCREW WAS RETRIEVED. THEY BELIEVE THE SCREW WAS 40MM LONG AND THEY REMOVED ABOUT 15-20MM OF THE BROKEN SCREW. THEY LEFT THE REST IN AS THEY DIDN¿T FEEL IT WAS SAFE OR RESPONSIBLE TO TRY TO GET THE REST OF IT OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 17644658 ↗MalfunctionAug 24, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A ARTHREX REPRESENTATIVE VIA SEMS THAT AN AR-8750-03 DRIVER SHAFT, T15 HEXALOBE, BROKE WHILE INSERTING A 5.0 COMPRESSION SCREW AND GOT STUCK INSIDE THE SCREW ITSELF. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17615895 ↗InjuryJul 10, 2023Break; Break
ON 6/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8750-03 DRIVER SHAFT, T15 HEXALOBE BROKE WHEN ADVANCING THE SCREW. SOME OF THE BROKEN FRAGMENTS WERE RETRIEVED, BUT THE REST REMAINS STUCK IN THE BONE. THIS WAS DISCOVERED DURING AN INTRAMEDULLARY METATARSAL FRACTURE ORIF PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED WITH A SECOND DRIVER. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 17287982 ↗MalfunctionMay 15, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED VIA EMAIL THAT AN AR-8750-03 (DRIVER SHAFT, T15 HEXALOBE, CANNULATED, ISO, AO) WAS BROKEN BY SURGEON DURING SURGERY. THIS OCCURRED ON (B)(6) 2023 AT AN UNSPECIFIED TIME WITH NO CASE INVOLVEMENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16934475 ↗MalfunctionMay 15, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED VIA EMAIL THAT AN AR-8750-03 (DRIVER SHAFT, T15 HEXALOBE, CANNULATED, ISO, AO) BROKE DURING USE. THIS OCCURRED ON (B)(6) 2023, AT AN UNSPECIFIED TIME WITH NO CASE INVOLVEMENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16929481 ↗InjuryMay 11, 2023Break; Break
IT WAS REPORTED THAT DURING A REVISION SURGERY FOR A REMOVAL OF AN ANKLE PLATE THE DEVICE BROKE INSIDE THE PATIENT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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: Failure of Implant
MAUDE report 16914625 ↗MalfunctionMay 11, 2023Break; Break
ON 4/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (QTY. 2) OF AN AR-8750-03 T15 DRIVER SHAFT, T15 HEXALOBE, CANNULATED, HAD AN ISSUE. DURING A HARDWARE REMOVAL OF 5.0 HEADLESS COMPRESSION SCREWS PROCEDURE, WHEN THE SURGEON TRIED TO GET THE SCREWS OUT BY HAND BOTH CANNULATED DRIVERS BROKE AT THE DRIVER¿S END WHERE THE TIP OF THE SCREW ENTERS THE HEAD OF THE SCREW. THE CASE WAS COMPLETED USING A SOLID DRIVER TO GET THE SCREWS OUT. THIS WAS DISCOVERED DURING USE, WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16913562 ↗MalfunctionMar 7, 2023Break; Break
ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8750-03 T15 HEXALOBE COMPRESSION SCREW BROKE DURING AN ANKLE ARTHRODESIS PROCEDURE. THE SCREW WAS BEING TIGHTENED ON THE HANDLE AND THE TIP OF THE SCREWDRIVER BROKE OFF INSIDE THE HEAD OF THE SCREW. ALL PIECES WERE REMOVED AND PLACED IN A BIOHAZARD BAG. AN X-RAY WAS OBTAINED TO MAKE SURE NO METAL PIECES WERE LEFT BEHIND. THE PROCEDURE WAS COMPLETED WITH NO ISSUES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 16494399 ↗MalfunctionJul 6, 2021Break
IT WAS REPORTED THAT WHEN THE SURGEON WAS REMOVING AN OLD 5.0 COMPRESSION SCREW, THE TIPS OF 2 OF THE DRIVERS BROKE. ALL FRAGMENTS WERE LOCATED AND REMOVED WITH USE OF X-RAY. ADDITIONAL INFORMATION PROVIDED (B)(6) 2021: THE PROCEDURE BEING PERFORMED WAS 5.0 HEADLESS SCREW REMOVAL. THE PART AND LOT NUMBER OF THE DEVICE WAS NOT PROVIDED AS HAS NOW BEEN DISCARDED. THE DRIVERS THAT WERE BROKE IN THE CASE WILL BE RETURNED FOR EVALUATION.
Patient problems: Insufficient Information
MAUDE report 12123159 ↗MalfunctionJun 14, 2021Break
IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE SURGEON WAS IMPLANTING THE SCREW AND TIP BROKE OFF. NO HARM TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 11991331 ↗MalfunctionJun 14, 2021Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A FULKERSON OSTEOTOMY, WHEN THE SURGEON WAS PLACING THE SCREWS, THE TIPS OF THE AR-8750-03 TWISTED OFF ON WERE STUCK ONTO THE SCREW, THIS ISSUE OCCURRED TWICE DURING THE PROCEDURE. BOTH FRAGMENTS WERE REMOVED FROM THE PATIENT. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11990939 ↗MalfunctionJun 14, 2021Material Twisted/Bent; Mechanical Jam
IT WAS REPORTED THAT DURING A FULKERSON OSTEOTOMY, WHEN THE SURGEON WAS PLACING THE SCREWS, THE TIPS OF THE AR-8750-03 TWISTED OFF ON WERE STUCK ONTO THE SCREW, THIS ISSUE OCCURRED TWICE DURING THE PROCEDURE. BOTH FRAGMENTS WERE REMOVED FROM THE PATIENT. NO PATIENT HARM REPORTED.
Patient problems: Insufficient Information
MAUDE report 11990926 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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