Arthrex® AR-8973L-38-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867295247), received between Apr 23, 2024 and Jul 8, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Break; Break

  ON (B)(6) 2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8973L-38-130 FIBULOCK NAIL BECAME OVERLY TIGHT DURING INSERTION AND COULD NOT BE FULLY SEATED. THE INSERTION SEQUENCE INVOLVED USING THE AR-8973DS, GUIDE PIN PLACEMENT, DRILLING WITH A 6.2 MM BIT FOLLOWED BY A 3.2 MM BIT AND INSERTING THE AR-8973L-38-130 FIBULOCK NAIL. DUE TO THE TIGHT FIT, THE NAIL WAS REMOVED FOR RE-DRILLING WITH A 4.0 MM BIT; HOWEVER, THE TIP OF THE NAIL REMAINED LODGED IN THE MEDULLARY CAVITY. A LONG GUIDEWIRE FROM A NON-ARTHREX PRODUCT WAS USED TO ACCESS THE CAVITY VIA THE FIBULAR HEAD AND DISLODGE THE RETAINED FRAGMENT DISTALLY, ALLOWING FOR REMOVAL. THE CASE WAS COMPLETED USING AN AR-8973L-30-130 FIBULOCK NAIL. THIS WAS DISCOVERED DURING A FIBULA FRACTURE PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 06/25/2025: THE AR-8973L-38-130 FIBULOCK NAIL TIP WAS LODGED IN THE MEDULLARY CAVITY AT A DEPTH OF 2/3 OF THE PRODUCT, AND THERE WAS RESISTANCE UPON INSERTION. THE TIGHTNESS OCCURRED PROGRESSIVELY UPON INSERTION. THE PATIENT'S BONE QUALITY WAS ASSESSED AS NORMAL. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440243 ↗
• InjuryMay 6, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 5/21/2025: ON (B)(6) 2025, AN ORIF ANKLE SURGERY WAS PERFORMED UTILIZING AR-8973L-38-130 ARTHREX FIBULOCK NAIL, AN AR-8973DS FIBULOCK IMPLANT SYSTEM, AN AR-8827-16 LOW PROFILE SCREW, AN AR-8827-18 LOW PROFILE SCREW, TWO AR-8925SS SYNDESMOSIS TIGHTROPE XP, AND AN AR-8934BCST-2 DOUBLE LOADED SUTURETAPE S-TAK ASSY. FOLLOWING THE SURGERY, IT WAS DETERMINED THAT THE FIBULAR NAIL HAD BROKEN, REQUIRING AN ADDITIONAL PROCEDURE TO STABILIZE THE FRACTURE. THE REVISION SURGERY TOOK PLACE APPROXIMATELY TWO WEEKS AFTER THE INITIAL PROCEDURE. DURING THE REVISION, THE BROKEN FIBULAR NAIL WAS REMOVED AND REPLACED WITH AN ARTHREX TTC NAIL TO COMPLETE THE REPAIR.

  Patient problems: Bone Fracture(s); Failure of Implant

  MAUDE report 21969857 ↗
• MalfunctionMay 1, 2025Positioning Failure; Positioning Failure

  ON 4/17/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-8973L-38-130 ARTHREX FIBULOCK NAIL HAD AN ISSUE DURING A FIBULA FRACTURE REPAIR PROCEDURE ON (B)(6) 2025. WHEN THE SURGEON USED THE NAIL, THE TALONS OF THE DEVICE WERE NOT DEPLOYED INSIDE THE PATIENT. NOTHING BROKE OFF THE FIBULOCK NAIL, AND THE DEVICE WAS REMOVED IN ONE PIECE FROM THE PATIENT; THERE WAS NO HARM. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. AN AR-8973L-38-180 ARTHREX FIBULOCK NAIL WITH LOT NUMBER 14895094 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CASE WAS DELAYED FOR 3-4 MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941854 ↗
• MalfunctionApr 23, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  ON 6/1/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8973L-38-130 FIBULOCK NAIL TALONS APPEARED TO BE SLIGHTLY DEPLOYED UPON OPENING PACKAGE. DURING INSERTION, THE TALONS WOULD NOT FULLY DEPLOY NOR RETRACT, THEREFORE, SURGEON REMOVED IT COMPLETELY AND USED A NEW FIBULOCK NAIL TO FINISH THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 6/1/2022: THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19163941 ↗