Arthrex® AR-8973DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867303041), received between Dec 20, 2018 and Mar 11, 2026 — classified as 12 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Fracture

  ON 18-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-8973DS FIBULOCK IMPLANT SYSTEM EXPERIENCED AN ISSUE. DURING A FIBULA FRACTURE REPAIR PROCEDURE PERFORMED ON (B)(6) 2026, THE SURGEON ATTEMPTED TO PLACE THE 1.6 MM GUIDEWIRE FROM THE PRODUCT ACROSS THE FRACTURE SITE. WHEN REAMING WAS PERFORMED WITH A 6.2 MM REAMER, THE GUIDEWIRE FRACTURED. THE BROKEN PORTION OF THE WIRE WAS RETRIEVED, AND THE SURGEON ELECTED TO SWITCH FIXATION TO A PLATE (NO DETAILED PART OR LOT INFORMATION PROVIDED). THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO SIGNIFICANT SURGICAL DELAY OCCURRED, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574342 ↗
• InjuryJul 8, 2025Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 07/08/2025: THE AR-8973DS FIBULOCK IMPLANT SYSTEM HAD THE END CAP IN THE KIT INSERTED INTO THE FIBULOCK NAIL DURING THE INITIAL PROCEDURE. DURING THE ROH/TTC REVISION, THE END CAP WAS REMOVED BEFORE THE EXTRACTION OF THE BROKEN FIBULAR NAIL. THE END CAP FROM THE AR-8973DS FIBULOCK IMPLANT SYSTEM DID NOT BREAK DURING THE PROCEDURE.

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

  MAUDE report 22437466 ↗
• InjuryFeb 24, 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 21447436 ↗
• 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 21035025 ↗
• InjurySep 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 8/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY FOR AN ANKLE FRACTURE AND SYNDESMOSIS REPAIR. DURING THE PROCEDURE, TWO AR-8730-36PT LOW PROFILE SCREW, TI, 3.0 MM X 36 MM, CANCELLOUS, PARTIALLY THREADED, AN AR-8827-18 LOW PROFILE SCREW, 2.7 X 18 MM, CORTEX, AN AR-8827-22 LOW PROFILE SCREW, 2.7 X 22 MM, CORTEX, AN AR-8973DS FIBULOCK IMPLANT SYSTEM, AN AR-8973L-38-180 ARTHREX FIBULOCK NAIL, 3.8 X 180 MM LEFT, AND AN AR-8925SS SYNDESMOSIS TIGHTROPE XP, STAINLESS STEEL WERE IMPLANTED. POST-OPERATIVE, THE PATIENT STARTED TO EXPERIENCE PAIN. ON (B)(6) 2024, REVISION SURGERY WAS PERFORMED TO REMOVE ALL THE IMPLANTS EXCEPT FOR THE AR-8973L-38-180 ARTHREX FIBULOCK NAIL. DURING THE REMOVAL OF THE IMPLANTS, THE DISTAL END OF THE EXTRACTION TOOL OF AN AR-8973RK FIBULOCK REMOVAL KIT BROKE OFF AFTER ROUGHLY 8 MALLET STRIKES. ANOTHER AR-8973RK FIBULOCK REMOVAL KIT WAS OPENED, AND THE SAME THING OCCURRED. THE EXTRACTION TOOLS BROKE, BUT NO PIECES WERE IN THE PATIENT. THE SURGEON ELECTED TO CLOSE AND FINISH THE CASE WITH THE NAIL STILL IMPLANTED AND FELT CONFIDENT THAT THE REMOVED

  Patient problems: Pain

  MAUDE report 20156940 ↗
• MalfunctionMay 27, 2024Defective Device; Defective Device

  ON 10/26/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8973DS FIBULOCK IMPLANT SYSTEM PACKAGE WITH STERILE INSTRUMENT, WAS NOT SEALED, AND ALL THE DRILL BITS FELL ON THE FLOOR. THIS WAS DISCOVERED PRIOR TO USE DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 10/28/2022: THIS WAS DISCOVERED DURING A FIBULOCK PROCEDURE ON (B)(6) 2022 AND WAS COMPLETED WITH A NEW AR-8973DS FIBULOCK IMPLANT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400163 ↗
• MalfunctionMay 6, 2024Difficult to Advance; Difficult to Advance

  ON 06/02/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973DS FIBULOCK IMPLANT SYSTEM HAD AN ISSUE. WHILE PERFORMING THE FIBULOCK PROCEDURE ON (B)(6)2022, THE SURGEON HAD DIFFICULTY ADVANCING THE 6.2MM REAMER OVER THE 1.6MM WIRE, EVEN WHILE APPLYING FORCE. THE REAMER WAS VERY DIFFICULT TO ADVANCE AND EVENTUALLY MADE ITS WAY TO THE DESIRED DEPTH. AFTER REMOVING THE REAMER THEY NOTICED THE WIRE WAS CHEWED/ABOUT TO BREAK SO THEY REPLACED IT WITH THE SECOND WIRE AND THE CASE WENT SMOOTHLY. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON 06/07/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THE DISTAL REAMER 6.2MM WAS VERY DIFFICULT TO ADVANCE INTO THE DISTAL FIBULA, NOT SPINNING VERY WELL. IT WAS NOTICED AFTER REAMING, THAT THE GUIDE WIRE WAS FRAYED 5-6 CM UP THE WIRE, HAD A DAMAGED SURFACE, AND WAS ABOUT TO BREAK, BUT DID NOT BREAK INSIDE THE PATIENT. THEY REMOVED THE WIRE IN ONE PIECE AND REPLACED IT WITH THE SECOND WIRE. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT, AND THE PATIENT WAS FINE TO DATE. NO FURTHER ACTION WAS REQUESTED, THE SALES REPRESENTATIVE JUST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19249460 ↗
• MalfunctionMay 3, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON 4/8/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE WIRE FROM AN AR-8973DS FIBULOCK IMPLANT SYSTEM WOULD NOT ADVANCE. UPON EXAMINATION OF BOTH WIRES, IT WAS DISCOVERED THAT THE TIPS WERE ROUNDED RATHER THAN SHARP. THE CASE WAS COMPLETED BY OPENING A NEW AR-8973DS FIBULOCK IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19237703 ↗
• MalfunctionMar 26, 2024Break; Break

  ON 03/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8973DS FIBULOCK® IMPLANT SYSTEMS WIRES BROKE OFF. THIS OCCURRED DURING A PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED. ADDITIONAL INFORMATION WAS PROVIDED ON 03/12/2024, WHERE THE SALES REPRESENTATIVE REPORTED THIS EVENT OCCURRED DURING A RIGHT FIBULA ORIF ON (B)(6) 2024, WHERE A SECOND AR-8973DS WAS USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION RECEIVED ON 3/15/2024: ALL BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18981168 ↗
• MalfunctionOct 3, 2023Defective Device; Defective Device

  ON 09/05/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06022345 THAT AN AR-8973DS FIBULOCK® IMPLANTS K-WIRES ARE WEAK. THIS WAS DISCOVERED DURING A CASE ON 08/25/2023, THAT THE 1.6 K WIRES IN THE FIBULOCK IMPLANT SYSTEM KIT WERE VERY FLIMSY AND EASILY MALLEABLE. THE CASE WAS ABLE TO BE COMPLETED, BUT THE SURGEON HAD SOME DIFFICULTY AND WAS CONCERNED ABOUT HOW WEAK THE K WIRES WERE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17863277 ↗
• InjuryJul 14, 2023Material Fragmentation; Material Fragmentation

  ON 6/16/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE OPENING REAMER FROM AN AR-8973DS FIBULOCK IMPLANT SYSTEM GOT CAUGHT ON THE WIRE AND COULD NOT ADVANCE. THE WIRE WAS REMOVED, AND THERE WAS A NOTICEABLE BEND AND A BUMP WHERE ON THE K-WIRE, WHERE THE DRILL LOOKED TO BE GETTING STUCK. ANOTHER WIRE WAS PLACED, AND A NEW KIT WAS OPENED BECAUSE THERE WERE SHAVINGS ON THE DRILL, BUT THE SAME THING HAPPENED AGAIN. THE SURGEON SWITCHED TECHNIQUES AND COMPLETED THE CASE WITH A PLATE INSTEAD. THIS WAS DISCOVERED DURING A FIBULOCK PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 6/16/2023: THIS WAS AN ANKLE FRACTURE PROCEDURE, AND A PLATE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE IT. THE SHAVINGS FROM THE DRILL WERE INSIDE THE PATIENT, BUT IT IS UNKNOWN IF EVERYTHING WAS RETRIEVED; IT WAS DIFFICULT TO SEE THROUGH THE X-RAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17327574 ↗
• MalfunctionDec 5, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE TIP OF K-WIRE FROM AN AR-8973DS FIBULOCK IMPLANT SYSTEM, BROKE DURING INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED BY OPENING ANOTHER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914228 ↗
• InjuryJun 20, 2022Break; Difficult to Advance

  ON 06/02/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973DS FIBULOCK IMPLANT SYSTEM HAD AN ISSUE. WHILE PERFORMING THE FIBULOCK PROCEDURE ON (B)(6) 2022, THE SURGEON HAD DIFFICULTY ADVANCING THE 6.2MM REAMER OVER THE 1.6MM WIRE, EVEN WHILE APPLYING FORCE. THE 1.6MM WIRE SNAPPED IN THE CANAL AFTER HAVING DIFFICULTY ADVANCING THE 6.2MM REAMER AND THE SURGEON HAD TO BAIL TO A PLATE. THE WIRE FRAGMENT WAS LEFT IN THE CANAL. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON (B)(6) 2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THE DISTAL REAMER 6.2MM WAS VERY DIFFICULT TO ADVANCE INTO THE DISTAL FIBULA, NOT SPINNING VERY WELL. THE GUIDE WIRE SNAPPED, THE FRAGMENT WAS LEFT IN THE CANAL, AND THE FRACTURE WAS PLATED INSTEAD WITH AN AR-8943BL OR BS LOCK DISTAL FIBULA PLATE, THE EXACT PART, AND LOT NUMBER WERE UNKNOWN. THIS RESULTED IN A DEVIATION FROM THE INTENDED PROCEDURE, AND THE CASE WAS COMPLETED SUCCESSFULLY THAT WAY, AND THE PATIENT WAS FINE TO DATE. THE SNAPPED PART OF THE WIRE WAS LEFT IN THE PATIENT, AND THE REST OF THE COMPLAINT DEVICE WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744274 ↗
• InjuryJun 20, 2022Break; Difficult to Advance

  ON 06/02/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8973DS FIBULOCK IMPLANT SYSTEM HAD AN ISSUE. WHILE PERFORMING THE FIBULOCK PROCEDURE ON (B)(6)2022, THE SURGEON HAD DIFFICULTY ADVANCING THE 6.2MM REAMER OVER THE 1.6MM WIRE, EVEN WHILE APPLYING FORCE. THE 1.6MM WIRE SNAPPED IN THE CANAL AFTER HAVING DIFFICULTY ADVANCING THE 6.2MM REAMER AND THE SURGEON HAD TO BAIL TO A PLATE. THE WIRE FRAGMENT WAS RETRIEVED THROUGH THE FRACTURE SITE. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ON 06/07/2022, THE SALES REPRESENTATIVE STATED THE FOLLOWING INFORMATION VIA PHONE: THE DISTAL REAMER 6.2MM WAS VERY DIFFICULT TO ADVANCE INTO THE DISTAL FIBULA, NOT SPINNING VERY WELL. THE GUIDE WIRE SNAPPED, THE FRAGMENT WAS RETRIEVED, AND THE FRACTURE WAS PLATED INSTEAD WITH AN AR-8943BL OR BS LOCK DISTAL FIBULA PLATE, EXACT PART, AND LOT NUMBER WAS UNKNOWN. THIS RESULTED IN A DEVIATION FROM THE INTENDED PROCEDURE, AND THE CASE WAS COMPLETED SUCCESSFULLY THAT WAY WITH NO IMPACT TO THE PATIENT, THE PATIENT WAS FINE TO DATE. THE COMPLAINT ITEM WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744234 ↗
• MalfunctionJun 28, 2021Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE 3.2 PROXIMAL REAMER AND GOLD TIP WIRE BROKE INSIDE THE MID SHAFT OF THE PATIENTS FIBULA. THE SURGEON WAS ABLE TO REMOVED THE 3.2 PROXIMAL REAMER FROM THE PATIENT BUT WAS UNABLE TO REMOVE THE TIP OF GOLD WIRE THAT BROKE. THE SURGEON THEN OPTED TO PLATE THE FIBULA DUE TO THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 12076013 ↗
• MalfunctionApr 1, 2021Break; Difficult to Remove

  IT WAS REPORTED BY THE SALES REP, THAT DURING AN ANKLE FRACTURE PROCEDURE, WHILE THE SURGEON WAS USING THE FIBULOCK NAIL, THE NAIL WAS INSERTED, TALONS ACTUATED AND DURING DRILLING OF THE DISTAL SCREWS THROUGH THE JIG, THE JIG WAS ROTATING CAUSING THE DRILL TO MISS THE SCREW HOLE IN THE NAIL AND A PIECE OF THE DRILL BROKE OFF IN THE PATIENT, AS WELL AS A PIECE OF THE BASE WHERE THE NAIL SCREWS ON TO THE JIG. THE DRILL BIT PIECE WAS UNABLE TO BE REMOVED AND WAS LEFT IN PATIENT. THE PIECE THAT BROKE OFF THE JIG WAS REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11602478 ↗
• MalfunctionMar 22, 2021Break; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED THAT THE LONG FLEXIBLE WIRE FROM THE AR-8973DS FIBULOCK IMPLANT SYSTEM WAS INTRODUCED AND ADVANCE UP THE FIBULA. 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: Foreign Body In Patient

  MAUDE report 11547674 ↗
• InjuryOct 5, 2020Break

  IT WAS REPORTED THAT A LONG FLEXIBLE SPADE TIP GUIDE WIRE FROM THE AR-8973DS FIBULOCK DISPOSABLE INSTRUMENTATION KIT BROKE DURING AN ANKLE FRACTURE FIBULOCK PROCEDURE. APPROXIMATELY 1.1MM GUIDEWIRE SPADE TIP REMAINS IN THE PATIENT. DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION OBTAINED 09/16/2020: THE FRAGMENT REMAINING IN THE PATIENT IS APPROXIMATELY 1.1MM WIDTH AND 2-5MM LENGTH. THE BROKEN TIP OF THE FLEXIBLE GUIDEWIRE WAS DISCOVERED UNDER X-RAY AFTER THE GUIDEWIRE WAS REMOVED FROM THE FIBULA AND THE IMPLANT WAS PLACED. NO X-RAYS WERE SAVED TO PROVIDE. THE SAME IMPLANT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL OR LARGER INCISIONS WERE NEEDED AND THE SURGEON DID NOT HAVE TO CHANGE HIS PLANNED TECHNIQUE. THE REMAINING PORTION OF THE GUIDEWIRE IS UNAVAILABLE TO RETURN FOR EVALUATION BECAUSE IT WAS CUT INTO PIECES FOR OTHER USE DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10631124 ↗
• InjuryNov 7, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANKLE FX PROCEDURE, AS THE SURGEON WAS INSERTING THE GUIDEWIRE THAT'S INCLUDED IN THE FIBULOCK IMPLANT SYSTEM, AR-8793DS, THE GOLD TIP BROKE OFF. THE TIP WAS UNABLE TO BE RETRIEVED FROM THE PATIENT AS IT WAS LODGED WITHIN THE BONE CANAL. AS THE SURGEON ATTEMPTED TO INSERT THE FIBLUOCK NAIL, HE FOUND DIFFICULTY REAMING PAST THE BROKEN FRAGMENT. HE WAS EVENTUALLY ABLE TO PUSH THE FRAGMENT TO THE SIDE AND INSERT THE FIBULOCK NAIL. A DELAY OF APPROXIMATELY 20 MIN INCURRED DUE TO THE BROKEN FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9289814 ↗
• InjuryNov 7, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANKLE FX PROCEDURE, AS THE SURGEON WAS INSERTING THE GUIDEWIRE THAT'S INCLUDED IN THE FIBULOCK IMPLANT SYSTEM, AR-8793DS, THE GOLD TIP BROKE OFF. THE TIP WAS UNABLE TO BE RETRIEVED FROM THE PATIENT AS IT WAS LODGED WITHIN THE BONE CANAL. A FIBULOCK NAIL WAS INSERTED INSIDE OF THE SAME TUNNEL IN WHICH THE TIP BROKE OFF IN, SECURING IT WITHIN THE BONE.

  Patient problems: Device Embedded In Tissue or Plaque; Tissue Damage

  MAUDE report 9289789 ↗
• InjuryMay 15, 2019Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANKLE FX PROCEDURE, THE SURGEON WAS USING A FIBULOCK IMPLANT SYSTEM, AR-8973DS. AFTER DRILLING, THE INITIAL K-WIRE SNAPPED OFF. THE DEVICE AND ITS BROKEN PIECE WERE RETRIEVED AND A SECOND K-WIRE WAS USED. DURING OVER-DRILLING FOR THE NAIL WITH THE 3.2 REAMER, THE SECOND K-WIRE SNAPPED. THE K-WIRE WAS LEFT IN THE FIBULA CANAL AND WAS IRRETRIEVABLE. ADDITIONAL INFORMATION PROVIDED 4/26/2019: THE SURGEON COMPLETED THE CASE USING AN ANKLE FRACTURE PLAYING SET. ROUGHLY 25% OF THE WIRE WAS LEFT IN THE FIBULA.

  Patient problems: Foreign Body In Patient

  MAUDE report 8611802 ↗
• InjuryDec 20, 2018Temperature Problem

  IT WAS REPORTED THAT AS THE SURGEON WAS DRILLING THE DISTAL PORTION OF THE FIBULA WITH THE 6.2 REAMER, THE IN6300 DOUBLE SIDED TISSUE PROTECTOR HEATED UP WHILE DRILLING, AND THE PATIENT'S TISSUE WAS BURNED. THE REP REPORTED THAT THE BONE QUALITY WAS HARD. ADDITIONAL INFORMATION RECEIVED ON 12/05/2018: THE REP STATED THAT THE 6.2 REAMER BEING USED WAS FROM AR-8973DS (LOT: 10239936). THE REP STATED THAT THE TISSUE WAS IN CONTACT WITH THE IN6300 DOUBLE SIDED TISSUE PROTECTOR, AND AS THE SURGEON WAS DRILLING WITH THE 6.2 REAMER, THE TISSUE PROTECTOR HEATED UP AND BURNED THE CONTACTED SKIN. THE REP REPORTED THAT THEY ARE UNAWARE OF THE SIZE OR APPEARANCE OF THE BURN MARK. THE REP STATED THAT THEY WERE MADE AWARE OF THE INCIDENT AT THE END OF THE PROCEDURE. THE REP STATED THEY DO NOT HAVE ANY INFORMATION AS TO HOW THE BURN IS BEING TREATED. IT WAS CONFIRMED THAT AN ARTHREX HANDPIECE WAS NOT BEING USED. THE REP CONFIRMED THAT THE PATIENT DID NOT HAVE TO STAY OVERNIGHT.

  Patient problems: Burn, Thermal

  MAUDE report 8184263 ↗