Arthrex® AR-8717G-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867326095), received between Nov 17, 2022 and Jun 18, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED DURING AN AKIN PROCEDURE WHILE DRILLING THE FIRST PILOT HOLE FOR A 9 X 10 STAPLE THE AR-8717D-01 1.6 DRILL GOT STUCK IN THE AR-8717G-01 GUIDE. THE REP STATED NOTHING COULD BE DONE WHILE IN OR TO FREE IT FROM THE GUIDE (MALLET AND PLIERS WERE ATTEMPTED AMONG OTHER THINGS). IT WAS LIKE THE INSTRUMENTS HAD ¿COLD FUSED¿ TOGETHER. IT WAS NOT UNTIL THE INSTRUMENTS WERE STILL HOT FROM THE WASHER THAT THE REP WAS ABLE TO SEPARATE THEM. YOU CAN SEE FROM INSPECTION THAT THERE IS DAMAGE TO THE DRILL AND INSIDE OF THE DRILL GUIDE. THE DRILL WILL NOT SLIDE FREELY THROUGH THE ONE SIDE. THIS IS THE A NEW SET AT THIS FACILITY AND THE FIRST TIME USED IN CASE. THE CASE WAS COMPLETED BY OPENING A STAPLE KIT (AR-8717DS-0910 / LOT: 0295107266) IN ORDER TO COMPLETE DRILLING FOR THE ALREADY OPENED STAPLE ONLY KIT.

  Patient problems: Insufficient Information

  MAUDE report 19561771 ↗
• MalfunctionJun 18, 2024Mechanical Jam; Mechanical Jam

  ON 03/29/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA PHONE THAT ON (B)(6) 2022 DURING A 4 CORNER FUSION A AR-8717DS-1110 DYNANITE STAPLE IMPLANT SYSTEMS DRILL BIT GOT BOUND UP IN THE DRILL GUIDE. THEN FOLLOWING THIS AN AR-8717DS-0910 DYNANITE STAPLE IMPLANT SYSTEMS DRILL BIT ALSO GOT BOUND UP IN THE DRILL GUIDE. THE SURGEON PROCEEDED TO GET 2 NEW KITS AND THOSE WORKED ACCORDINGLY. A AR-8717G-01 DRILL GUIDE, AND A AR-8717G-02 DRILL GUIDE ALSO GOT BOUND UP. THE CASE WAS COMPLETED HOWEVER THE SURGEON WAS NOT PLEASED WITH THE PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19561228 ↗
• MalfunctionJun 5, 2024Mechanical Jam; Mechanical Jam

  ON 02/14/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8717D-01 DRILL BIT COLD WELDED TO THE AR-8717G GUIDE WHILE DRILLING HOLES FOR THE STAPLE. THE AR-8717G-01 (LOT 04511920) WAS THE ONLY GUIDE IN THE SET, SO THE SURGEON HAD TO COMPLETED THE TUNNEL WITHOUT USING A GUIDE. THE SURGEON WAS ABLE TO INSERT THE STAPLE AND COMPLETE THE PROCEDURE. PICTURE ATTACHED I HAD TO USE PLIERS TO WIGGLE/PRY THE DRILL OUT AFTER THE CASE. PLEASE NOTE THE SMALL METAL SHAVINGS. I WANTED TO REPORT THIS INCIDENT FROM FRIDAY: (I THINK) IT WAS THE ONLY GUIDE IN THE SET, SO THE SURGEON (DR (B)(6) ) HAD TO GUESSTIMATE WITH ANOTHER DRILL TO COMPLETE THE TUNNELS. IT WASN¿T IDEAL, BUT HE WAS ABLE TO INSERT THE STAPLE AND COMPLETE THE PROCEDURE. THE PATIENT WAS A MALE IN HIS 30S WITH HARD BONE. I HAD TO USE PLIERS TO WIGGLE/PRY THE DRILL OUT AFTER THE CASE. PLEASE NOTE THE SMALL METAL SHAVINGS AR-8717D-01 (031922), AR-8717G-01 (04511920).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467862 ↗
• MalfunctionApr 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A CASE, WHEN DRILLING WITH THE AR-8717D-01-RU, THE DRILL LOCKED IN THE AR-8717G-01 PARALLEL GUIDE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164662 ↗
• MalfunctionNov 17, 2022Mechanical Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING AN SKIN SURGERY IT WAS DIFFICULT TO MOVE THE DRILL THROUGH THE DRILL GUIDE. HOWEVER THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. AFTER THE SURGERY IT WAS NOTICED THAT THE DRILL IS DAMAGED AND SHOWED SIGNS OF ABRASION. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814969 ↗