Arthrex® AR-18700-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867303553), received between Jun 30, 2020 and May 28, 2025 — classified as 3 injuries, 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Break; Break

  ON 05/06/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE TIP OF THE AR-18700-29 DRIVER SHAFT BROKE OFF IN THE HEAD OF THE AR-18714V-06 VAL SCREW AS THE SURGEON WAS ADVANCING IT INTO THE AR-18714P-21 HOOK PLATE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE AR-18700-29 DRIVER SHAFT WAS BEING USED WITH THE JEWELER'S KNOB HANDLE AR-18700H. THE SURGEON WANTED TO REPLACE THE SCREW, BUT THE ONLY WAY TO REMOVE IT WAS TO CUT THE TINES OFF THE AR-18714P-21 HOOK PLATE, REMOVE EACH TINE FROM THE PATIENT, AND ROTATE THE PLATE COUNTERCLOCKWISE TO BACK OUT THE LOCKING SCREW. THE CASE WAS COMPLETED, AND NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING AN ORIF MIDDLE PHALANX FRACTURE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 05/27/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097928 ↗
• MalfunctionJun 20, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-18700-29 T-4 DRIVER BROKE OFF IN THE TIP OF THE CORTICAL SCREW WHILE INSERTING IT INTO THE PLATE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THIS WAS DISCOVERED DURING A PROXIMAL PHALANX FX PROCEDURE. NOTHING BROKE INSIDE THE CASE AND IT WAS COMPLETED SUCCESSFULLY WITH AN AR-18700-09 T-4 DRIVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742790 ↗
• MalfunctionJun 6, 2022Degraded; Material Split, Cut or Torn

  ON 04/18/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT (2) AR-18700-03 DRIVER SHAFTS ARE RUSTED, AND STRIPPED. ALSO AN AR-18700-29 DRIVER SHAFT, HALF OF THE TIP BROKE-OFF. THIS WAS DISCOVERED ON (B)(6) 2022 DURING A ULNA AND RADIUS ORIF. THE CASE WAS COMPLETED USING A MOSQUITO CLAMP AS THERE WAS NO OTHER DRIVER AVAILABLE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602203 ↗
• MalfunctionMar 8, 2021Break; Device Slipped; Improper or Incorrect Procedure or Method; Material Twisted/Bent

  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: Insufficient Information

  MAUDE report 11437296 ↗
• InjurySep 10, 2020Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A METACARPAL FRACTURE PROCEDURE THE SURGEON WAS USING AN AR-18700-29, T-4 DRIVER SHAFT (LOT 1391940), TO SCREW A VARIABLE ANKLE LOCKING SCREW INTO A 1.4 Z-PLATE. THE TIP OF THE DRIVER SHAFT BROKE OFF IN THE SCREW HEAD. THE SURGEON WAS UNABLE TO REMOVE THE TIPS FROM THE SCREW HEAD. THE SCREW WAS SITTING FLUSH WITH THE PLATE. NO ADDITIONAL INCISIONS OR CHANGE OF TECHNIQUES WERE NEEDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10516780 ↗
• InjuryJul 29, 2020Break; Difficult to Remove

  IT WAS REPORTED DURING A PROCEDURE THE TIP OF THE AR-18700-29 DRIVER SHAFT BROKE OFF INTO THE SCREW. THE REP REPORTED IT WAS THE FIRST SCREW GOING IN USING THIS SCREWDRIVER. THE TIP BROKE OFF FLUSH INSIDE THE SCREW AND WAS LEFT INSIDE THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 7/15/2020: THE PROCEDURE BEING PERFORMED WAS A PIP FRACTURE. THE SURGEON ATTEMPTED TO REMOVE THE BROKEN DRIVER TIP FROM THE SCREW, BUT DECIDED TO LEAVE IT AS THEY WERE WORRIED ABOUT TRYING TO HARD AND LOSING FIXATION. THE SCREW WAS DOWN ENOUGH THAT IT COULD REMAIN IMPLANTED AND EFFECTIVELY COMPLETE THE PROCEDURE. THE REMAINING PORTION OF THE SCREWDRIVER IS RETURNING FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10337690 ↗
• InjuryJun 30, 2020Break

  IT WAS REPORTED THAT WHILE INSERTING A 1.4 LOCKING SCREW INTO THE 1.4 CAGE SCREW THE DRIVER, AR-18700-29, BROKE OFF IN THE SCREW HEAD. REPORTER STATES PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION OBTAINED 6/8/20: THE LOT NUMBER OF THE AR-18700-29 WAS LOT 1391940. PROCEDURE WAS A PHALANX FRACTURE. THE SCREWDRIVER TIP WAS LEFT IN THE HEAD OF THE SCREW, UNRETRIEVED INSIDE THE PATIENT. THE SCREW AS FULLY SEATED. THE SURGEON USED ANOTHER SCREW DRIVER THAT WAS IN THE INSTRUMENT SET TO COMPLETE THE PROCEDURE. THE AR-18700-29 WAS DISCARDED BY THE FACILITY BEFORE THE SALES REP WAS ABLE TO RETRIEVE IT FOR EVALUATION. DEVICE WILL NOT BE RETURNED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10212011 ↗