Arthrex® AR-8973L-30-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867295209), received between Jun 27, 2019 and Dec 29, 2025 — classified as 3 injuries, 12 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Break; Break

  ON 08-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT ONE OF THE PROXIMAL TALONS OF AN AR-8973L-30-130 ARTHREX FIBULOCK NAIL, 3.0 X 130 MM LEFT, BROKE OFF INSIDE THE PATIENT DURING NAIL INSERTION. THIS WAS DISCOVERED DURING A FIBULOCK PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-8973L-30-130 ARTHREX FIBULOCK NAIL (3.0 MM X 130 MM). THE SURGERY EXPERIENCED AN APPROXIMATE ONE-HOUR DELAY; ADMINISTRATION OF ADDITIONAL ANESTHESIA COULD NOT BE CONFIRMED. DURING THE PROCEDURE, ONE PROXIMAL TALON FRACTURED AND REMAINED UNRETRIEVABLE WITHIN THE FIBULAR CANAL. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED, AND NO ADDITIONAL SURGERY IS PLANNED DUE TO THE ISSUE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908469 ↗
• MalfunctionApr 30, 2025Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  ON 28TH APRIL 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8973L-30-130, ARTHREX® FIBULOCK® NAIL, 3.0 X 130 MM LEFT, THE TALONS DEPLOYED DURING INSERTION OF NAIL PRIOR TO THE SURGEON USING THE ACTUATION DRIVER. AS THE SURGEON WAS ADVANCING THE NAIL INTO POSITION, THE TALONS DEPLOYED HENCE THE SURGEON WAS UNABLE TO ADVANCE ANY FURTHER. THIS WAS DETECTED DURING USE IN AN ANKLE FRACTURE WITH FIBULAR NAIL PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE NAIL WAS REMOVED AND REPLACED.

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

  MAUDE report 21935416 ↗
• MalfunctionMar 19, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON 03/04/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8973L-30-130 ARTHREX® FIBULOCK® NAILS TALONS WOULD NOT DEPLOY. THIS OCCURRED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2024 WHEN THE SURGEON WENT TO ADVANCE THE NAIL THAT THE TALONS WOULD NOT DEPLOY. ANOTHER AR-8973L-30-130 ARTHREX® FIBULOCK® NAIL WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM. THE PATIENT DID NOT HAVE A GREAT BONE QUALITY. THIS RESULTED IN A FEW MINUTES DELAY WHILE REMOVING THE NAIL. ADDITIONAL ANASTHESIA IS NOT BELIEVED TO HAVE BEEN ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642406 ↗
• InjuryFeb 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, A PATIENT CONTACTED CUSTOMER SERVICE REQUESTING THE MATERIAL COMPOSITION OF A RIGHT FIBULA NAIL 3.0 BY 130 MM. NO ALLEGATION OF PRODUCT DEFICIENCY OR ADVERSE EVENT WAS REPORTED WITHIN THIS INQUIRY. ON (B)(6) 2025, THE PATIENT REPORTED VIA PHONE TO HAVE BEEN EXPERIENCING DIFFICULTY WALKING AND CONSTANT PAIN. THE PATIENT STATED THAT THE SCREWS APPEAR TO BE PROTRUDING AND CAN BE SEEN ON THE SKIN OF THE KNEE. THE PATIENT UNDERWENT TIBIAL SURGERY DUE TO AN ACCIDENT ABOUT A YEAR AND A HALF AGO IN WHICH SCREWS AND THE TIBIAL NAIL WAS IMPLANTED. THE PATIENT REPORTS TO BE HIGHLY ALLERGIC TO TITANIUM; HOWEVER, POST OPERATION, THE PATIENT HAD A THREE WEEKLONG METAL TESTING, WHICH CAME BACK NEGATIVE FOR ALLERGIES. THE PATIENT WAS NOT TESTED FOR ALLERGIES PRIOR TO THE SURGERY. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 2/14/2025: IT WAS REPORTED BY THE PATIENT VIA EMAIL THAT AN AR-8973DS FIBULOCK IMPLANT SYSTEM, A 1109-300 TIBIAL NAIL, AN 8001-040 CAPTURED CORTICAL SCREW, TWO 8001-034 CAPTURED CORTICAL SCREW, TWO 8001-044 CAPTURED CORTICAL SCREW, AN AR-8973L-30-130 ARTHREX FIBULOCK NAIL, AN AR-8830-16 FULLY THREADED CANCELLOUS SCREW, AND AN AR-89

  Patient problems: Pain

  MAUDE report 21468463 ↗
• MalfunctionDec 30, 2024Failure to Advance; Failure to Advance

  ON 12/3/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8973L-30-130 ARTHREX FIBULOCK NAIL PROXIMAL TALONS WERE NOT OPENING. THE PROXIMAL TALON DRIVER WAS NOT SEATED FULLY, THERE WAS A GAP OF APPROXIMATELY 2 MM GAP, WHICH PREVENTED THE ACTUATION OF THE TALONS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6)2024. THE CASE WAS COMPLETED USING ANOTHER AR-8973L-30-130 ARTHREX FIBULOCK NAIL. ADDITIONAL INFORMATION RECEIVED ON 12/13/2024: THE ACTUATION DRIVER FROM THE AR-8973DS FIBULOCK IMPLANT SYSTEM WOULD NOT FULLY SEAT AND THE TALONS ON THE NAIL COULD NOT OPEN. THIS WAS DISCOVERED DURING A BIMALLEOLAR ANKLE FRACTURE PROCEDURE. THE CASE WAS DELAYED ABOUT TEN MINUTES TO OPEN A NEW NAIL AND AVOID FURTHER DELAYS.

  Patient problems: Insufficient Information

  MAUDE report 21035026 ↗
• MalfunctionDec 6, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8973L-30-130 ARTHREX FIBULOCK NAIL TALONS DID NOT ACTUATE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 11/14/2024: THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE. UPON INSERTION OF THE FIBULOCK NAIL, THE TALONS DID NOT DEPLOY. THE CASE WAS COMPLETED USING ANOTHER AR-8973L-30-130 ARTHREX FIBULOCK NAIL FROM A DIFFERENT LOT NUMBER. THE CASE WAS NOT DELAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864592 ↗
• MalfunctionAug 13, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8973L-30-130 ARTHREX FIBULOCK NAIL WAS NOT WORKING PROPERLY; THE TALONS THAT OPEN ON THE TIP WOULD NOT DEPLOY ONCE IN THE PATIENT. ANOTHER NEW AR-8973L-30-130 ARTHREX FIBULOCK NAIL WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 08/01/2024: THIS WAS DISCOVERED DURING A FIBULOCK (FIBULA FRACTURE) PROCEDURE ON (B)(6) 2024. THE CASE WAS NOT DELAYED AND WAS COMPLETED BY OPENING A NEW IMPLANT. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972813 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT THE LONG FLEXIBLE WIRE FROM THE AR-8973DS FIBULOCK IMPLANT SYSTEM WAS INTRODUCED AND ADVANCE UP THE FIBULA DURING A FIBULA OPEN REDUCTION INTERNAL FIXATION PROCEDURE. WHEN THE 3.2MM REAMER WAS INTRODUCED AND ADVANCED UP THE FIBULA, THE DEVICE CAME TO A HARD STOP. WHEN ATTEMPTING TO ADVANCE THE 3.2MM REAMER UP THE FIBULA FURTHER, THE FLEXIBLE WIRE THAT WAS BEING REAMED OVER BROKE IN HALF. THE BROKEN FLEXIBLE WIRE WAS LEFT IN THE FIBULA AND THE AR-8973L-30-130 FIBULOCK NAIL WAS INSERTED PER TECHNIQUE GUIDE. THE PROXIMAL TIP OF THE FIBULOCK NAIL CAME INTO CONTACT WITH THE BROKEN END OF THE WIRE AND AS THE FIBULOCK NAIL PASSED BY THE BROKEN WIRE, THE PROXIMAL TIP OF THE FIBULOCK BENT. THE FIBULOCK NAIL AND FLEXIBLE WIRE WERE BOTH LEFT IN THE FIBULA AS THE FRACTURE WAS REDUCED AND THE DOCTOR DID NOT HAVE A PROBLEM LEAVING IT IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19546704 ↗
• MalfunctionMay 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 2/15/2022, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8973L-30-130 FIBULOCK NAIL TALONS DID NOT FULLY DEPLOY. SURGEON REMOVED THE 1.6 GUIDEWIRE AND INSERT THE LEFT FIBULOCK NAIL WITH THE OUT TRIGGER DIRECTLY LATERAL TO THE LEG. BEFORE THE TALONS ARE ACTIVATED, SURGEON PLACED A 1.6MM K-WIRE TO CONFIRM THE NAIL POSITION ON FLUOROSCOPY. THE NAIL WAS FLUSHED IN THE FIBULA. THEN, SURGEON REMOVE THE IMPACTOR CAP AND INSERT THE ACTUATION DRIVER, HELD THE OUT TRIGGER AND TURN THE ACTUATION DRIVER TO DEPLOY THE TALONS. ONLY TWO CLICK SOUNDS WERE HEARD AND THERE WERE MORE SOUND. THE TALONS DID NOT DEPLOY FULLY. SURGEON CHECKED WITH FLUOROSCOPY AND THE DEPLOYMENT OF TALONS WAS NOT SIGNIFICANT. SURGEON COULD NOT REMOVE THE NAIL. THE NAIL IS INTACT INSIDE THE PATIENT FIBULA. SURGEON USED TWO 2.7MM SCREWS TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A LEFT ANKLE NAILING WITH FIBULOCK PROCEDURE. NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19400027 ↗
• MalfunctionApr 25, 2024Use of Device Problem; Use of Device Problem

  ON 1/6/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8973L-30-130 ARTHREX FIBULOCK NAIL WHEN WAS IMPLANTED, A CLICKED SOUND WAS HEARD AND THE NAILED DID NOT ENGAGE. SURGEON OPENED A SEPARATE KIT AND ATTEMPTED TO USE THE HANDLE FROM THAT KIT ON THE NAIL BUT STILL, THE NAIL DID NOT TURN. FINALLY, SURGEON REMOVED THE NAIL FROM INSIDE THE PATIENT AND OPENED A NEW AR-8973L-30-130 ARTHREX FIBULOCK NAIL FROM A DIFFERENT LOT NUMBER. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE FIBULAR NAIL PROCEDURE ON (B)(6)2022. CASE WAS COMPLETED SUCCESSFULLY WITH OUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180874 ↗
• MalfunctionJun 19, 2023Break; Break

  ON (B)(6) 2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8973L-30-130 FIBULA NAIL HAD AN ISSUE. DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2023 WHEN THE SURGEON INSERTED THE NAIL, HE MET RESISTANCE IN THE FIBULA AND PULLED IT OUT. WHEN THE DEVICE WAS PULLED OUT, IT WAS NOTICED THAT THE TIP OF THE NAIL HAD BROKEN OFF INSIDE THE FIBULA. THE BROKEN TIP WAS BURIED DEEP INTO THE FIBULA AND COULD NOT BE REMOVED FROM THE PATIENT. THE SURGEON DEEMED IT SAFE TO LEAVE IT INSIDE THE PATIENT'S FIBULA. A DRILL BIT WAS USED TO MALLET THE TIP DEEPER INTO THE FIBULA, AND THEN ANOTHER AR-8973L-30-130, WITH LOT 15033165 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 17152374 ↗
• MalfunctionJun 20, 2022Break; Difficult to Insert

  ON 5/31/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8973L-30-130 ARTHREX FIBULOCK NAIL TIP BROKE. THE SURGEON INSERTED THE NAIL AFTER REAMING AND BECAUSE IT WAS NOT INSERTING EASILY, SURGEON GAVE IT TWO LIGHT TAPS WITH A MALLET. AFTER SEEING THE NAIL WAS NOT MOVING, SURGEON REAMED AGAIN AND WHEN THE NAIL WAS PULLED OUT, THE TIP WAS BROKE OFF JUST ABOVE THE TALONS AND STILL INSIDE THE PATIENT. SURGEON WAS ABLE TO PUSH IT OUT OF THE WAY WITH THE REAMER AND COMPLETE THE PROCEDURE WITH A SECOND NAIL. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14742763 ↗
• MalfunctionMar 22, 2021Break

  IT WAS REPORTED DURING AN ANKLE FRACTURE REPAIR THE IMPLANT BROKE ON INSERTION. A SECOND INCISION HAD TO BE MADE TO RETRIEVE THE BROKEN IMPLANT. ALL WAS RETRIEVED AND NO FRAGMENTS REMAINED IN THE PATIENT. IT WAS REPLACED WITH ANOTHER AR-8973L-30-130 WITH A DIFFERENT LOT NUMBER AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: Failure of Implant

  MAUDE report 11545926 ↗
• InjuryJan 18, 2021Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT UPON DOING THE INITIAL 3.0 REAMING OVER THE FLEXIBLE GUIDE PIN, THE TIP OF THE GUIDE PIN BROKE OFF IN THE PROXIMAL FIBULA. THIS WASN'T NOTICED ON X-RAY UNTIL THE IMPLANT WAS FIXATED AND FINAL X-RAYS WERE TAKEN. THE PIN WAS PUSHED FURTHER UP THE FIBULA DURING IMPLANTATION. THE DOCTOR DID NOT WANT TO LEAVE THE BROKEN PIN IN THE BONE AND CHOSE TO REMOVE THE HARDWARE. IN ORDER TO DO SO, A PROXIMAL DRILL HOLE WAS MADE AT THE DISTAL END OF THE PIN TO REMOVE THE PIN. THIS TOOK SOME TIME. ONCE REMOVED, THE CURRENT NAIL IMPLANT WAS INSERTED TO BE RE-IMPLANTED. THE PROXIMAL TALONS WERE ATTEMPTED TO DEPLOY BUT BONE DEBRIS OR SOMETHING WAS CAUSING THE NUT TO NOT FULLY PUSH OUT THE TALONS. THIS IMPLANT WAS REMOVED AND ANOTHER FIBULOCK IMPLANT WAS OPENED TO COMPLETE THE CASE. TWO EXTRA INCISIONS WERE MADE IN THIS CASE BECAUSE OF THE HARDWARE REMOVAL. ONE AS MENTIONED IN THE PROXIMAL FIBULA AND THE SECOND IN THE MEDIAL TIBIA TO REMOVE THE SYNDESMOSIS BUTTON. ADDITIONAL INFORMATION PROVIDED 1/8/2021: PROCEDURE WAS A FIBULA ORIF WITH SYNDESMOSIS.

  Patient problems: Failure of Implant

  MAUDE report 11186476 ↗
• InjuryJun 27, 2019Fracture; Labelling, Instructions for Use or Training Problem; Use of Device Problem; Failure to Align

  IT WAS REPORTED DURING A PRIMARY PERCUTANEOUS PROCEDURE THAT TOOK PLACE ON (B)(6) 2019, THE SURGEON WAS ATTEMPTING TO PUT A SONOMA 3.5 X 55 ((B)(4) / LOT: A17111705 ) SCREW INTO THE AR-8973L-30-130 FIBULA NAIL (LOT: 10297815), BUT THE SCREW WOULD NOT LINE UP AND THE SURGEON COULD NOT GET THE RIGHT TRAJECTORY. THE SURGEON WAS ABLE TO ACHIEVE GOOD FIXATION WITHOUT USING THE SCREW. THE FIBULA NAIL WAS LEFT IMPLANTED, AND THE CASE WAS COMPLETED SUCCESSFULLY. THE PATIENT CAME IN FOR A FOLLOW UP VISIT ON (B)(6) 2019 AND DURING THE FOLLOW-UP VISIT IT WAS DISCOVERED THAT THE PATIENT AMBULATED ON THE NAIL POST-OPERATIVELY AND RE-FRACTURED THEIR FIBULA. A REVISION/REMOVAL PROCEDURE TOOK PLACE ON (B)(6) 2019, AND WAS PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY. DURING THE REVISION PROCEDURE, THE AR-8973L-30-130 WAS SUCCESSFULLY REMOVED. UPON REMOVAL, IT WAS DISCOVERED THAT THE DEVICE IS LABELED AS AN AR-8973L-30-130 (LEFT) NAIL, BUT THE DEVICE IS ACTUALLY A RIGHT NAIL. THE NAIL WAS REINSERTED ON THE JIG, AND UPON FURTHER INVESTIGATION ALL HOLES LINED UP AS A RIGHT NAIL. IT WAS ALSO DISCOVERED THAT THE LOT NUMBER ETCHED ON THE DEVICE IS DIFFERENT THAN THE LOT NUMBER THAT WAS ON THE ORIG

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739490 ↗