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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 2 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

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