Arthrex® AR-18800-03Recalls & reported problems
Arthrex, Inc. · Driver Shaft, T6, Self Retaining, AO · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex T6 self-retaining driver shaft is a hand tool used to place bone fixation screws during orthopedic surgery. The 30 reports describe shafts that twist or warp, and tips that break or shear off, sometimes leaving a fragment in the screw head that has to be picked out, and screws that no longer hold. There are no deaths and no injuries. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867385566), received between Dec 7, 2023 and Dec 23, 2025 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (17 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
- Material Twisted/Bent17
- Break12
- Material Deformation2
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information4
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Break; Break
ON 12/02/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT TIPS WERE BREAKING AND NOT HOLDING SCREWS. THE SCREWS WERE SNAPPING OFF. THIS WAS DISCOVERED DURING THE CASE. THE TIP WAS RETRIEVED, AND THE CASE WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879017 ↗MalfunctionNov 4, 2025Material Twisted/Bent; Material Twisted/Bent
ON 10/27/2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVE SHAFT IS TWISTED AT THE TIP. NOTICED DURING A CASE, SWAPPED, AND COMPLETED WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23466832 ↗MalfunctionAug 29, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
ON 08/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVE SHAFT IS WARPED. NOTICED AFTER STERILIZATION WITH NO PATIENT EFFECT. ADDITIONAL INFO 8/14/25: THE DRIVER WARPED DURING THE CASE. THE TIP SHEARED OFF IN THE SCREW HEAD CAUSING THE DOCTOR TO HAVE TO PICK IT OUT WITH A DENTAL PICK. THE PIECE WAS DISPOSED OF IN THE OR. THEY CONTINUED THE CASE WITH THE SECONDARY DRIVER SHAFT IN THE SET. NO SIGNIFICANT DELAY OR ADVERSE EFFECTS WERE EXPERIENCED AS A RESULT OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921777 ↗MalfunctionMar 20, 2025Material Twisted/Bent; Material Twisted/Bent
ON 03/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT IS TWISTED. THIS OCCURRED AFTER USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21650912 ↗MalfunctionFeb 5, 2025Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation
ON 01/09/2025 A SALES REPRESENTATIVE REPORTED, VIA (B)(4), THAT AN AR-18800-03 DRIVER SHAFT, T6, SELF-RETAINING, WAS NO LONGER VIABLE FOR INSERTING THE IMPLANT AND WAS TORQUED. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 1/13/2025: THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2025. AN ADDITIONAL DRIVER IN THE SET WAS USED TO COMPLETE THE CASE. THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21313264 ↗MalfunctionDec 6, 2024Material Twisted/Bent; Material Twisted/Bent
ON 11/08/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT AND AR-18800-04 DRIVER SHAFT ENDS ARE TWISTED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863535 ↗MalfunctionNov 4, 2024Material Twisted/Bent; Material Twisted/Bent
ON 10/16/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.(B)(4) AR-18800-03 T6 SELF-RETAINING DRIVER SHAFTS ARE TWISTED, BROKEN AND UNUSABLE. THE BROKEN DRIVER SHAFT HAS BEEN DISCARDED AT THE FACILITY. THIS WAS DISCOVERED DURING A CASE. NO, THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. WE WERE ABLE TO FINISH THE CASE WITH THE BENT DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20599044 ↗MalfunctionNov 4, 2024Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT TWO (QTY.2) AR-18800-03 T6 SELF-RETAINING DRIVER SHAFTS ARE TWISTED, BROKEN AND UNUSABLE. THE BROKEN DRIVER SHAFT HAS BEEN DISCARDED AT THE FACILITY. THIS WAS DISCOVERED DURING A CASE. NO, THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. WE WERE ABLE TO FINISH THE CASE WITH THE BENT DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20599029 ↗MalfunctionOct 31, 2024Material Twisted/Bent; Material Twisted/Bent
ON 10/15/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT WAS TWISTED. THE CASE CONTINUED AND WAS COMPLETED SUCCESSFULLY WITH BACKUP PARTS. THIS WAS DISCOVERED DURING A TMT FUSION PROCEDURE ON 10/14/2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577806 ↗MalfunctionOct 21, 2024Material Twisted/Bent; Material Twisted/Bent
ON 09/27/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4). THAT (QTY.2) OF AN AR-18800-03 DRIVER SHAFTS TWISTED AT THE TIP WHILE INSERTING A LOCKING SCREW AND NO LONGER USABLE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20498781 ↗MalfunctionOct 17, 2024Material Twisted/Bent; Material Twisted/Bent
ON 09/27/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06673460 THAT (QTY.2) OF AN AR-18800-03 DRIVER SHAFTS TWISTED AT THE TIP WHILE INSERTING A LOCKING SCREW AND NO LONGER USABLE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20472830 ↗MalfunctionOct 17, 2024Material Twisted/Bent; Material Twisted/Bent
ON 09/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT TIP BROKE OFF INSIDE THE PATIENT WHILE INSERTING THE SCREW, AND AN AR-18800-03 DRIVER SHAFT WAS WARPED. THE CASE WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A 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 20470868 ↗MalfunctionOct 17, 2024Break; Break
ON (B)(6) 2024 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06672663 THAT AN AR-18800-03 DRIVER SHAFT TIP BROKE OFF INSIDE THE PATIENT WHILE INSERTING THE SCREW, AND AN AR-18800-03 DRIVER SHAFT WAS WARPED. THE CASE WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A 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 20470773 ↗MalfunctionOct 8, 2024Break; Break
ON (B)(6) 2024, A SALES REPRESENTATIVE VIA (B)(4) REPORTED THAT (QTY. 2) OF AN AR-18800-03 DRIVER SHAFT BROKE/TWISTED DURING A CASE. THE SURGEON STATED THAT HE COULD HAVE DONE MORE AND WAS NOT CRANKING ON THE SCREWS. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397308 ↗MalfunctionOct 8, 2024Break; Break
ON (B)(6) 2024, A SALES REPRESENTATIVE VIA SEMS-06665153 REPORTED THAT (QTY. 2) OF AN AR-18800-03 DRIVER SHAFT BROKE DURING A CASE. THE SURGEON STATED THAT HE COULD HAVE DONE MORE AND WAS NOT CRANKING ON THE SCREWS. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20397235 ↗MalfunctionAug 27, 2024Break; Break
08/01/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT AND AN AR-18800-04 DRIVER SHAFTS TIPS SNAPPED IN THE LOCKING SCREWS. THIS OCCURRED DURING A CASE WITH NO HARM TO THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 20074989 ↗MalfunctionJul 17, 2024Material Twisted/Bent; Material Twisted/Bent
ON 06/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06601486 THAT AN AR-18800-03 DRIVER SHAFT BROKE DURING A CASE WITH NO FURTHER INFORMATION PROVIDED. ANOTHER DEVICE WAS SWAPPED AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED ON 7/1/2024: THE TIP OF THE DRIVER WAS TWISTED DUE TO THE TORQUE PLACED ON DRIVER. THIS OCCURRED DURING AN ORIF CLAVICLE PROCEDURE ON (B)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19763405 ↗MalfunctionJul 17, 2024Break; Break
ON 06/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT BROKE DURING A CASE WITH NO FURTHER INFORMATION PROVIDED. ANOTHER DEVICES WAS SWAPPED AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19761569 ↗MalfunctionMay 23, 2024Break; Break
ON 4/25/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT IS BROKEN. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19387671 ↗MalfunctionMay 17, 2024Material Twisted/Bent; Material Twisted/Bent
ON 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING A PROCEDURE MULTIPLE DEVICES FAILED. DURING THE PROCEDURE AN AR-18800-04 DRIVER SHAFT BECAME TWISTED, AN AR-18800-04 DRIVER SHAFT SNAPPED OFF, (2) AR-18800-03 DRIVER SHAFTS WERE TWISTED, AN AR-18700-39 TORQUE LIMITING ADAPTER WAS NOT CLICKING WHEN THE TORQUE WAS REACHED, A AR-18800-05 SOLID SCREWDRIVER WAS TWISTED, AND A AR-18700-45 POINTED REDUCTION FORCEPS WOULD NOT CLOSE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 19343734 ↗MalfunctionMay 17, 2024Material Twisted/Bent; Material Twisted/Bent
ON 04/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT DURING A PROCEDURE MULTIPLE DEVICES FAILED. DURING THE PROCEDURE AN AR-18800-04 DRIVER SHAFT BECAME TWISTED, AN AR-18800-04 DRIVER SHAFT SNAPPED OFF, (2) AR-18800-03 DRIVER SHAFTS WERE TWISTED, AN AR-18700-39 TORQUE LIMITING ADAPTER WAS NOT CLICKING WHEN THE TORQUE WAS REACHED, A AR-18800-05 SOLID SCREWDRIVER WAS TWISTED, AND A AR-18700-45 POINTED REDUCTION FORCEPS WOULD NOT CLOSE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 19343574 ↗MalfunctionMay 9, 2024Break; Break
ON 04/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-18800-03 DRIVER SHAFTS AND (2) AR-18800-04 DRIVER SHAFTS WERE WARPED AND BREAKING. THIS OCCURRED DURING AN ORIF ANKLE PROCEDURE ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 19278117 ↗MalfunctionMay 9, 2024Break; Break
ON 04/16/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-18800-03 DRIVER SHAFTS AND (2) AR-18800-04 DRIVER SHAFTS WERE WARPED AND BREAKING. THIS OCCURRED DURING AN ORIF ANKLE PROCEDURE ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.
Patient problems: Insufficient Information
MAUDE report 19278018 ↗MalfunctionApr 11, 2024Material Twisted/Bent; Material Twisted/Bent
ON 3/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT (2) AR-18800-03 DRIVER SHAFT AND AN AR-18800-05 SOLID SCREWDRIVER WERE TWISTED DURING SURGERY. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 4/10/2024: THIS WAS DISCOVERED DURING AN ORIF PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING THE TWISTED DRIVERS. THERE WAS NO REPORTED DELAY IN THE CASE OR ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19091094 ↗MalfunctionApr 11, 2024Material Twisted/Bent; Material Twisted/Bent
ON 3/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (2) AR-18800-03 DRIVER SHAFT AND AN AR-18800-05 SOLID SCREWDRIVER WERE TWISTED DURING SURGERY. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 4/10/2024: THIS WAS DISCOVERED DURING AN ORIF PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING THE TWISTED DRIVERS. THERE WAS NO REPORTED DELAY IN THE CASE OR ADVERSE EFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19091052 ↗
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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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