Arthrex® AR-18700-09Recalls & reported problems
Arthrex, Inc. · Driver Shaft, T4, Self Retaining,Mini AO · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867313781), received between Jan 26, 2021 and Mar 31, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break6
- Material Twisted/Bent1
Patient problems
- Foreign Body In Patient2
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Failure of Implant1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT DURING A HAND ARTHROSCOPY THE TIP OF THE SCREWDRIVER BROKE OFF WHILE THE SURGEON INSERTED THE SCREW. THE BROKEN PIECE WAS RETRIEVED OUT OF 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 24741663 ↗MalfunctionOct 11, 2024Material Twisted/Bent; Material Twisted/Bent
ON 09/20/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-18700-09 DRIVER SHAFT WAS TWISTED. THIS OCCURRED DURING A CASE THAT CARRIED ON AND WAS COMPLETED SUCCESSFULLY WITH BACKUP PARTS.
Patient problems: Insufficient Information
MAUDE report 20426726 ↗MalfunctionJul 3, 2024Break; Break
ON 06/06/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-18700-09 DRIVER SHAFT AND AN AR-18700-29 DRIVER SHAFTS TIPS BROKE OFF. THIS OCCURRED DURING A CASE WHERE THE DRIVERS BROKE OFF INTO THE AR-1871V-08 SCREW HEAD IN THE AR-18714P-12 PLATE. ONE OF THE TIPS FROM AN AR-18700-29 DRIVER COULD NOT BE RETRIEVED AS IT COLD WELDED TO THE SCREW.
Patient problems: Insufficient Information
MAUDE report 19668804 ↗MalfunctionJul 3, 2024Break; Break
ON 06/06/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-18700-09 DRIVER SHAFT AND AN AR-18700-29 DRIVER SHAFTS TIPS BROKE OFF. THIS OCCURRED DURING A CASE WHERE THE DRIVERS BROKE OFF INTO THE AR-1871V-08 SCREW HEAD IN THE AR-18714P-12 PLATE. ONE OF THE TIPS FROM AN AR-18700-29 DRIVER COULD NOT BE RETRIEVED AS IT COLD WELDED TO THE SCREW.
Patient problems: Foreign Body In Patient
MAUDE report 19668335 ↗MalfunctionJun 14, 2021Break
IT WAS REPORTED DURING A PROCEDURE THE AR-18716P-10 PLATE WAS DAMAGED DURING THE ATTEMPTED CUT AND THE TIP OF THE AR-18700-09 DRIVER BROKE OFF INTO THE SCREW HEAD. ADDITIONAL INFORMATION PROVIDED 6/8/21: THE BROKEN TIP OF AR-18700-09 WAS UNABLE TO BE REMOVED FROM THE SCREW HEAD. THE DRIVER TIP BROKE COMPLETELY FLUSH WITHIN THE SCREW HEAD AND THE SURGEON WAS UNABLE TO REMOVE IT. THE CASE WAS COMPLETED BY REMOVING THE ENTIRE SCREW FROM THE PATIENT USING A NEEDLE NOSE PLIERS, AND USING A LESS OPTIMAL PLATE BECAUSE THE MOST OPTIMAL PLATE WE NEEDED WAS BENT DURING AN ATTEMPTED CUT. BOTH DEVICES WERE DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11991278 ↗MalfunctionMar 12, 2021Break
IT WAS REPORTED, THAT DURING A PROXIMAL PHALANX FRACTURE OF THE 2ND FINGER REPAIR PROCEDURE, AS THE SURGEON WAS INSERTING THE SCREW WHEN THE TIP OF THE AR-18700-09, DRIVE SHAFT BROKE. THE BROKEN PIECE WAS REMOVED. THE SURGEON USED AN AR-18700-29, DRIVE SHAFT, FOR INSERTION OF THE LAST SCREW, THE SURGEON COULD FEEL THE TIP OF THE DRIVER WAS TWISTING AND BACKED OFF REMOVING THE AR-18700-29. THE CASE WAS COMPLETED LEAVING THE SCREW NOT FULLY SEATED.
Patient problems: Failure of Implant
MAUDE report 11475942 ↗MalfunctionJan 26, 2021Break
IT WAS REPORTED THAT DURING A (B)(6) 2021 SMALL FINGER METACARPAL ORIF PROCEDURE THE TIP OF AN AR18700-09, DRIVER SHAFT (LOT 1391937), BROKE OFF IN THE HEAD OF A SCREW IN THE PATIENT. THE TIP OF THE DRIVER WAS UNABLE TO BE RETRIEVED AND REMAINS IN THE SCREW HEAD THAT IS IMPLANTED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11230961 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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