Arthrex® AR-8973-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00888867301832), received between Aug 20, 2019 and Apr 21, 2026 — classified as 6 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break

  ON 01-APR-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8973-01 OUTRIGGER TARGETING GUIDE IS CRACKED. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944882 ↗
• MalfunctionMar 9, 2026Break

  ON 16-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE PRONGS ON FIBULOCK NAIL JIG WERE BROKEN OFF. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543830 ↗
• MalfunctionFeb 24, 2026Positioning Failure

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8973-01 OUTRIGGER TARGETING GUIDE IS MISALIGNED. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429449 ↗
• InjuryOct 15, 2025Break; Break

  ON 10/06/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE BROKE WHILE TRYING TO SCREW ON THE FIBULOCK NAIL, WHERE THE PEGS WERE STRIPPED OFF. THEY TRIED TO SCREW THE NAIL ON, BUT THE SCREW HOLES NO LONGER MATCHED UP WITH THE JIG. THERE WERE NO FRAGMENTS PRODUCED. THE PROCEDURE WAS MODIFIED TO PLATING AS A RESULT OF THE BREAK.

  Patient problems: Insufficient Information

  MAUDE report 23300245 ↗
• MalfunctionMar 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 03/07/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE WOULD NOT ALLOW THE ATTACHMENT SCREW ROD TO PASS THROUGH ITS RESPECTIVE SHEATH TO ENGAGE THE NAIL AND HOLD IT TO THE OUTRIGGER. IT SEEMS THERE IS A SCREW HALFWAY DOWN THE SHEATH OF THE OUTRIGGER THAT BLOCKS THE ATTACHMENT SCREW ROD. THE SCREW APPEARS TO BE PART OF THE OUTRIGGER, BUT THERE IS NO WAY TO REMOVE IT AS IT LOOKS INTERNAL. NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667468 ↗
• MalfunctionFeb 5, 2025Break; Break

  ON 01/15/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE BROKE DURING A CASE. THE TWO TINES WHERE THE NAIL ATTACHES SNAPPED OFF DURING INSERTION (SEE PHOTOS). THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311677 ↗
• MalfunctionFeb 5, 2025Break; Break

  ON 01/14/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDES ATTACHMENT PIECE FOR THE NAIL, THE METAL SHEERED OFF. THIS OCCURRED DURING A CASE, AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311284 ↗
• MalfunctionJan 13, 2025Break; Break

  ON 12/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-(B)(4) THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE BROKE DURING A CASE WHILE SCREWING THE NAIL INTO THE JIG, IT SPIRALED (SEE PHOTOS). THE CASE WAS COMPLETED SUCCESSFULLY WITH THE NAIL STAYING ON DURING THE CASE. NO PIECES BROKE OFF INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE 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 21143577 ↗
• MalfunctionOct 29, 2024Break; Break

  ON 10/11/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE BROKE DURING USE (SEE PHOTO ATTACHMENT). THE CASE WAS COMPLETED SUCCESSFULLY, WITH NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557299 ↗
• MalfunctionOct 9, 2024Break; Break

  ON 10TH OCTOBER 2024: THE SALES REP. UPDATED THAT WHEN AR-8973RK WAS BEING USED TO REMOVE THE NAIL NOTHING BROKE AND EVERYTHING WAS INTACT AND THE NAIL WAS SIMPLY INCORPORATED INTO THE BONE TOO TIGHTLY TO BE REMOVED. THERE IS NO FOLLOW-UP SURGERY PLANNED TO COMPLETE THE PROCEDURE AS THE PATIENT WAS ALREADY COUNSELED PRIOR TO SURGERY ABOUT THE POSSIBILITY OF LEAVING THE NAIL IN PLACE AS THERE WAS NO MEDICAL INDICATION FOR IMPLANT REMOVAL. THERE WERE NO MEDICAL ISSUES. THE NAIL WAS IMPLANTED IN A WAY THAT A PART OF IT WAS PROMINENT, WHICH BOTHERED THE PATIENT WHICH WAS THE REASON FOR THE SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20410508 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT THE TABS ON THE END OF THE AR-8973-01 FIBULOCK JIG WHERE THE NAIL FITS ONTO WERE BROKEN OFF SOMEHOW. NOTHING AFFECTED THE PATIENT OR WAS BROKEN OFF INSIDE THE PATIENT. THE REP REPORTED THE BREAKAGE MUST HAVE HAPPENED IN THE WASH AFTER THE PREVIOUS CASE OR SOMETHING PRIOR TO THE CASE. THE ISSUE MADE FOR A DIFFICULT CASE BUT THE END RESULT WAS PERFECT. SEE SOURCE DATA AND IMAGE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566015 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE AR-8973-01 OUTRIGGER TARGETING GUIDE NEEDS TO BE REPLACED. SEE SOURCE DATA ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 1/25/21: THE REP REPORTED THAT THE AR-8973-01 HAS A CHIPPED PIECE ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557286 ↗
• MalfunctionJun 14, 2024Break; Break

  IT WAS REPORTED ON 12/30/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973-01 OUTRIGGER TARGETTING GUIDE BROKE. NO CASE INVOLVEMENT, NO PATIENT EFFECT. PER FACILITY: "THE SURGEON NOTICED WHILE LOADING THE 3.0X130 LEFT FIBULOCK NAIL ONTO THE OUTRIGGER ONE TOOTH THAT CAPTURES THE NAIL WAS CHIPPED OFF. THIS MUST HAVE HAPPENED ON PRIOR CASE WITHOUT OUR REPRESENTATIVES NOTICING. XRAYS WERE OBTAINED TO MAKE SURE NO METAL WAS LEFT IN THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED. NO OTHER SURGERIES WERE NECESSARY. THE NAIL WAS INSERTED WITH NO ISSUES AND PROCEDURES COMPLETED AS NECESSARY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537329 ↗
• MalfunctionJun 4, 2024Break; Break

  ON 28-FEB-2023, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT AN AR-8973-01, OUTRIGGER TARGETING GUIDE INSERTER TIP BROKE. IT WAS DAMAGED BY THE HOSPITAL WHEN PROCESSING OUT POST CASE. THIS WAS DISCOVERED AFTER USE AND NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456769 ↗
• MalfunctionMay 25, 2024Break; Break

  IT WAS REPORTED ON 04/18/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-8973-01 TARGETING GUIDE IS BROKEN. THIS WAS DISCOVERED AFTER THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398292 ↗
• MalfunctionMay 24, 2024Defective Device; Defective Device

  ON 03/18/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A AR-8973-01 TARGETING GUIDE IS DAMAGED. THIS WAS DISCOVERED DURING AN UNKNOWN TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397277 ↗
• MalfunctionMay 23, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT WHILE THE AR-8973-01 TARGETING GUIDE WAS BEING USED IN AN ANKLE FIXATION, THE PROXIMAL TIGHTROPE HOLE FOR A RIGHT ANKLE WAS OUT OF ALIGNMENT I.E. THE TIGHTROPE WOULD HAVE MISSED THE NAIL HAD THE SURGEON DRILLED THROUGH THE DRILL GUIDE AND OUTRIGGER. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382639 ↗
• MalfunctionMay 6, 2024Break; Break

  ON 9/06/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE IS HAVING ISSUES. THE NAIL WOULD NOT SCREW ONTO THE JIG DUE TO THE TWO PEGS BEING MISSING. THIS WAS NOTICED IT IN THE CASE BEFORE IT WENT INSIDE THE PATIENT. NO PATIENT AFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249541 ↗
• MalfunctionMay 6, 2024Break; Break

  ON 03/28/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE HAD A MALFUNCTION WITH THE ITEM. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON 03/29/2022, ANOTHER SALES REPRESENTATIVE, MR. (B)(6), STATED THE FOLLOWING INFORMATION VIA PHONE: THE EVENT OCCURRED DURING AN ANKLE FRACTURE REPAIR ON (B)(6) 2022. WHEN THE SURGEON WAS USING THE OUTRIGGER TARGETING GUIDE TO IMPLANT THE FIBULOCK IMPLANT, IT WAS NOTICED THAT THE BOBBINS ON THE TIP OF THE DEVICE WERE MISSING WHERE THE NAIL SEATED. NO PIECES BROKE OFF INSIDE THE PATIENT, THE MISSING PARTS MAY HAVE BROKEN IN A PREVIOUS CASE. THE COMPLAINT DEVICE WAS ABLE TO BE USED TO SEAT THE IMPLANT AND COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249153 ↗
• MalfunctionMay 6, 2024Defective Device; Defective Device

  ON 11/22/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT A AR-8973-01 TARGETING GUIDE IS DEFECTIVE. THIS WAS DISCOVERED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248310 ↗
• MalfunctionApr 29, 2024Break; Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 8973-01 OUTRIGGER TARGETING GUIDE CRACKED AND ONE OF THE TWO PIECES ON THE TIP OF THE METAL ALSO BROKE. THE BROKEN TIP COULD NOT BE FOUND, AND IT WAS ASSUMED THAT IT FELL TO THE GROUND. THIS WAS DISCOVERED DURING A FIBULOCK PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 12/21/2022: X-RAY WAS TAKEN DURING THE PROCEDURE WHICH CONFIRMED THE BROKEN PIECE WAS NOT INSIDE THE PATIENT. THIS PROCEDURE TOOK PLACE ON (B)(6) 2022. CASE WAS COMPLETED IN NORMAL FASHION AS THE NAIL WAS ALREADY SECURED INTO THE JIG WITH THE TWIST KNOB. THE CRACK AND BROKEN JIG WAS NOT NOTICED UNTIL AFTER IMPLANTATION AND THE JIG WAS BROUGH TO THE BACK TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202686 ↗
• MalfunctionApr 26, 2024Defective Device; Defective Device

  IT WAS REPORTED THE AR-8973-01 OUTRIGGER TARGETING GUIDE WAS FOUND TO BE MALFUNCTIONING. THE HUB ATTACHMENT, AR-8973-03, BECOMES JAMMED AND DIFFICULT TO INSERT AND REMOVE FROM THE AR-8973-01.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19190503 ↗
• MalfunctionFeb 9, 2024Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT THE OUTRIGGER TARGETING GUIDE, AR-8973-01, IS MISSING THE PART THAT CONNECTS TO THE NAIL TO ENSURE IT¿S LINED UP CORRECTLY. FOUND DURING A CASE, NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676178 ↗
• MalfunctionAug 29, 2023Break; Break

  ON 07/31/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE BROKE. THIS OCCURRED DURING A PROCEDURE, ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE DEVICE WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17644789 ↗
• MalfunctionJul 10, 2023Break; Break

  ON 06/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973-01 OUTRIGGER TARGETING GUIDE BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2023.THERE WAS NO ADDITIONAL INFORMATION PROVIDED ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286687 ↗