Arthrex® AR-18800-25Recalls & reported problems
Arthrex, Inc. · Driver Shaft, T10, Non-retaining · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867385603), received between Aug 8, 2023 and Oct 7, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Twisted/Bent1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2024Material Twisted/Bent; Material Twisted/Bent
ON 09/12/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(6) THAT AN AR-18800-25 DRIVER SHAFT WARPED DURING A CASE. THE CASE WAS COMPLETED USING A BACKUP DRIVER IN THE TRAY, AND THERE WAS NO DELAY. THIS WAS DISCOVERED DURING A FOOT AND ANKLE RECONSTRUCTION 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 20382759 ↗MalfunctionJul 17, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 06/27/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-18800-25 DRIVER SHAFT AND AR-8700RH RATCHETING HANDLE HAS BEEN COLD WELDED TOGETHER. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19763678 ↗MalfunctionAug 8, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-18800-25 DRIVER SHAFT BROKE DURING THE INSERTION OF THE 2.7MM SCREW. THE BONE SOCKET WAS PREPARED WITH A 2.0MM DRILL, THE SCREW WAS INSERTED WITH POWER, AND THE DRIVER TIP BROKE WHEN IT HIT THE PLATE. ALL THE BROKEN FRAGMENTS WERE RETRIEVED AND CONFIRMED VIA X-RAY THAT NOTHING WAS LEFT BEHIND IN THE PATIENT. ANOTHER AR-18800-25 DRIVER SHAFT WAS USED TO CONTINUE THE IMPLANTATION OF THE SCREW. THIS WAS DISCOVERED DURING A TIBIA ORIF PROCEDURE ON (B)(6) 2023.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17480001 ↗
Other Orthopedic manual surgical instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page