Arthrex® AR-18800-04Recalls & reported problems
Arthrex, Inc. · Driver Shaft, T6, Non-Retaining, AO · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867385573), received between Oct 6, 2023 and Feb 4, 2025 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (8 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/Bent8
- Break6
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information4
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2025Material Twisted/Bent; Material Twisted/Bent
ON 01/14/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-04 DRIVER SHAFT AND AN AR-18800-05 SOLID SCREWDRIVER WERE TORQUED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21306929 ↗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 20863666 ↗MalfunctionNov 15, 2024Material Twisted/Bent; Material Twisted/Bent
ON 10/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-04 DRIVER SHAFT TWISTED DURING THE CASE. THE CASE WAS COMPLETED SUCCESSFULLY WITH BACKUP DRIVERS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694873 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent
ON 10/21/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-04 DRIVER SHAFT TWISTED DURING THE CASE. THE CASE WAS COMPLETED SUCCESSFULLY WITH BACKUP DRIVERS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609792 ↗MalfunctionOct 17, 2024Break; Break
ON 09/26/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-04 DRIVER SHAFT TIP BROKE OFF INSIDE THE PATIENT INSIDE THE SCREW HEAD, AND AN AR-18800-04 DRIVER SHAFT WAS WARPED. THE CASE WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE ON 09/19/2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20471337 ↗MalfunctionOct 17, 2024Material Twisted/Bent; Material Twisted/Bent
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-04 DRIVER SHAFT TIP BROKE OFF INSIDE THE PATIENT INSIDE THE SCREW HEAD, AND AN AR-18800-04 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 20471212 ↗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 19344086 ↗MalfunctionMay 17, 2024Break; Break
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 19343918 ↗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 19278255 ↗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 19278165 ↗MalfunctionApr 15, 2024Material Twisted/Bent; Material Twisted/Bent
ADDITIONAL INFORMATION WAS RECEIVED ON 3/25/2024: THIS WAS AFTER A METATARSAL FX PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19111880 ↗MalfunctionMar 4, 2024Break; Break
ON 02/15/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 DRIVER SHAFT AND AR-18800-04 DRIVER SHAFT BROKE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18827564 ↗MalfunctionFeb 23, 2024Material Deformation; Material Deformation
ON 02/6/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-04 DRIVER SHAFT AND AN AR-18800-03 DRIVER SHAFT WARPED WHEN TIGHTENING THE SCREWS. THIS WAS DISCOVERED DURING A PROCEDURE; THE PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18771075 ↗MalfunctionDec 7, 2023Material Twisted/Bent; Material Twisted/Bent
ON 11/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA A (B)(4) THAT (2) AR-18800-04 DRIVER SHAFTS AND AN AR-18800-03 DRIVER SHAFT BECAME TWISTED. THIS OCCURRED DURING A CASE, WITH NO EFFECT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18286126 ↗MalfunctionOct 6, 2023Break; Break
ON 9/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-03 SELF RETAINING DRIVE SHAFT AND AN AR-18800-04 NON-RETAINING DRIVER SHAFT HAD AN ISSUE. WHILE INSERTING A CORTICAL SCREW, THE AR-18800-03 SELF RETAINING DRIVE SHAFT STARTED TO TORQ OUT AND WASN'T RETAINING SCREWS. THE DEVICE WAS SWITCHED TO AN AR-18800-04 NON-RETAINING DRIVER SHAFT, AND WHILE INSERTING ANOTHER SCREW, THE DRIVER'S HEAD BROKE OFF INSIDE THE SCREW HEAD. THE PIECE WAS RECOVERED, AND THE CASE WAS COMPLETED BY SWITCHING TO A SOLID BLUE HANDLE T6 DRIVER IN THE TRAUMA MINI FRAG TRAY 2.0 SCREW CADDY. THIS WAS DISCOVERED DURING A MET SHAFT FRACTURE PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 9/19/2023: THERE WAS A 1-5 MINUTE DELAY IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17890291 ↗
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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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