Arthrex® AR-1688-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888867096080), received between Oct 12, 2016 and Sep 25, 2026 — classified as 14 injuries, 8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Deformation

  Patient problems: Insufficient Information

  MAUDE report 50897770 ↗
• InjurySep 9, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2025, IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE VIA MAIL THAT THE PATIENT UNDERWENT A MODIFIED BROSTROM LATERAL ANKLE STABILIZATION SURGERY OF THE LEFT FOOT ON (B)(6) 2019. DURING THE PROCEDURE, TWO AR-1688-CP INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEMS WERE USED. FOR OVER A YEAR FOLLOWING THE SURGERY, THE PATIENT CONTINUED TO REPORT ONGOING PAIN IN THE LEFT FOOT DURING POST-OPERATIVE VISITS. ON (B)(6) 2020, X-RAYS WERE TAKEN, AND IT WAS REPORTED TO THE PATIENT THAT THE HARDWARE WAS INTACT, IN PROPER POSITION, AND WELL SEATED. DESPITE THIS, THE PATIENT CONTINUED TO REPORT PAIN DURING VARIOUS FOLLOW-UP VISITS. THE OPERATING SURGEON ADVISED CONTINUED PATIENCE WITH CONSERVATIVE MEASURES AND TREATMENT. ON (B)(6) 2020, THE PATIENT SOUGHT ANOTHER SURGICAL OPINION. A RECENT MRI WAS REVIEWED, REVEALING A DEFECT IN THE SUBTALAR JOINT, AND THE PATIENT WAS INFORMED THAT SURGERY MIGHT BE REQUIRED TO ADDRESS THE DEFECT. FOLLOWING NEARLY TWO YEARS OF CONTINUED PAIN AND NO MEANINGFUL IMPROVEMENT, AND AFTER CONSULTING MULTIPLE SURGEONS, THE PATIENT WAS INFORMED ON (B)(6) 2021 THAT THE LATERAL LIGAMENT REPAIR ANCHOR HAD PENETRATED THE SUBTALAR JOINT AND WAS THE SO

  Patient problems: Pain

  MAUDE report 23006337 ↗
• InjurySep 9, 2025Malposition of Device; Malposition of Device

  ON 8/11/2025, IT WAS REPORTED BY A PATIENT¿S LEGAL REPRESENTATIVE VIA MAIL THAT THE PATIENT UNDERWENT A MODIFIED BROSTROM LATERAL ANKLE STABILIZATION SURGERY OF THE LEFT FOOT ON (B)(6) 2019. DURING THE PROCEDURE, TWO AR-1688-CP INTERNALBRACE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEMS WERE USED. FOR OVER A YEAR FOLLOWING THE SURGERY, THE PATIENT CONTINUED TO REPORT ONGOING PAIN IN THE LEFT FOOT DURING POST-OPERATIVE VISITS. ON (B)(6) 2020, X-RAYS WERE TAKEN, AND IT WAS REPORTED TO THE PATIENT THAT THE HARDWARE WAS INTACT, IN PROPER POSITION, AND WELL SEATED. DESPITE THIS, THE PATIENT CONTINUED TO REPORT PAIN DURING VARIOUS FOLLOW-UP VISITS. THE OPERATING SURGEON ADVISED CONTINUED PATIENCE WITH CONSERVATIVE MEASURES AND TREATMENT. ON (B)(6) 2020, THE PATIENT SOUGHT ANOTHER SURGICAL OPINION. A RECENT MRI WAS REVIEWED, REVEALING A DEFECT IN THE SUBTALAR JOINT, AND THE PATIENT WAS INFORMED THAT SURGERY MIGHT BE REQUIRED TO ADDRESS THE DEFECT. FOLLOWING NEARLY TWO YEARS OF CONTINUED PAIN AND NO MEANINGFUL IMPROVEMENT, AND AFTER CONSULTING MULTIPLE SURGEONS, THE PATIENT WAS INFORMED, ON (B)(6) 2021, THAT THE LATERAL LIGAMENT REPAIR ANCHOR HAD PENETRATED THE SUBTALAR JOINT AND WAS THE SO

  Patient problems: Pain

  MAUDE report 23006328 ↗
• MalfunctionJul 23, 2024Break; Break

  ON 07/02/2024 A SALES REPRESENTATIVE REPORTED VIA SEMS- (B)(4) THAT AN AR-1688-CP IMPLANT SYSTEM INTERNAL BRACE BLACK 3.5MM BIOCOMPOSITE SWIVELOCK TIP BROKE OFF DURING INSERTION WHILE DOING AN INTERNAL BRACE. THE 3.5 BLACK SWIVELOCK TIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THEY OPENED A NEW INTERNAL BRACE TO FINISH THE REPAIR, WHICH WORKED SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A LATERAL LIGAMENT REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806252 ↗
• MalfunctionJun 19, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED DURING AN ANKLE RECONSTRUCTION IT WAS DISCOVERED THE TRIP DOT WAS TRIPPED. THE DOT ON THE OUTSIDE PACKAGE WAS NOT TRIPPED BUT THE INSIDE DOT WAS. THIS WAS DISCOVERED IN THE MIDDLE OF THE CASE. IT WAS REPLACED WITH ANOTHER IMPLANT AND CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565982 ↗
• MalfunctionMay 27, 2024Failure to Advance; Failure to Advance

  ON 11/15/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1688-CP IMPLANT SYSTEMS ANCHOR FAILED PRIOR TO IMPLANTATION. THIS OCCURRED DURING A CASE WHEN THE ANCHOR FAILED PRIOR TO IMPLANTATION, IT WOULD NOT ADVANCE AFTER DRILLING THE PILOT HOLE. A NEW AR-1688-CP WAS OPENED AND THE CASE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 19400744 ↗
• MalfunctionMay 7, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE AR-1688-CP, THE EYELET HAS PULLED COMPLETELY THROUGH THE ANCHOR BODY AFTER BEING INSERTED. THE CASE WAS COMPLETED BY USING A NEW AR-1688-CP ADDITIONAL INFORMATION PROVIDED 6/15/21: THE PROCEDURE WAS AN INTERNAL BRACE. THE DEVICE DID NOT BREAK IN THE PATIENT. NO BROKEN PIECES REPORTED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260372 ↗
• MalfunctionJan 10, 2024Break; Material Fragmentation; Break; Material Fragmentation

  ON 12/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1688-CP IMPLANT SYSTEM, INTERNAL BRACE, AND LIGAMENT AUGMENTATION REPAIR HAD AN ISSUE. THE DRILL GOT BOUND UP IN THE DRILL GUIDE AND BROKE WITH NO BROKEN FRAGMENTS INSIDE THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-1688-CP FROM A DIFFERENT LOT WITH A FIVE-MINUTE REPORTED DELAY IN THE PROCEDURE. THIS WAS DISCOVERED DURING AN ACL INTERNAL BRACE PROCEDURE ON (B)(6) 2023.

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

  MAUDE report 18489221 ↗
• MalfunctionMay 16, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE DRILL IN THE DRILL GUIDE FROM AN AR-1688-CP INTERNAL BRACE IMPLANT SYSTEM PRODUCED METAL SHAVINGS. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 4/27/2023: ALL THE LOOSE DEBRIS WAS REMOVED FROM INSIDE THE PATIENT, AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A BROSTROM REPAIR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939046 ↗
• MalfunctionOct 31, 2022Break

  ON 10/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A 3.5MM SWIVELOCK FROM AN AR-1688-CP INTERNAL BRACE IMPLANT SYSTEM, ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN INTERNAL BRACE PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698363 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A REACTION TO AN INTERNAL BRACE IMPLANTED IN (B)(6) 2019. THE PATIENT UNDERWENT A ¿PERC¿ APPROACH IB WITH THE FIRST GENERATION SYSTEM. THEY ALSO HAD A DX SUTURETAPE FIBERTAK IMPLANTED DURING THE PRIMARY BROSTROM REPAIR. A HARDWARE REMOVAL TOOK PLACE ON (B)(6) 2020. ATTACHED IS THE CT SCAN, AS WELL AS CASE PHOTOS OF THE REMOVED HARDWARE. THE PATIENT HAD A REACTION TO THE IMPLANTED PRODUCT THAT CAUSED DETERIORATION OF THE CORTICAL BONE IN BOTH THE TALUS AND FIBULA. NO BONY INGROWTH OCCURRED IN EITHER THE 4.75/3.5 SWIVELOCK AND BOTH WERE REMOVED WITH EASE. THE REP STATED ALL EXPLANTED HARDWARE WAS SENT OUT FOR CULTURES/ LABS ON (B)(6) 2020 AND THE SURGEON PLANS TO REPORT BACK TO THE REP ONCE THE RESULTS ARE RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPDATE 04/14/2020: NUMEROUS ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT. DUE TO THE CURRENT COVID-19 PANDEMIC THE PRACTITIONER'S OFFICE HAS BEEN CLOSED AND AT THIS TIME OBTAINING ADDITIONAL INFORMATION WILL BE DIFFICULT. THE SALES REP WILL CONTINUE TO REACH OUT TO THE SURGEON/ FACILITY AND ONCE ADDITIONAL INFORMATION IS OBTAINED IT WILL BE PROVIDED TO ARTHREX

  Patient problems: Pain; Reaction; Swelling

  MAUDE report 10133102 ↗
• InjuryMay 28, 2020Malposition of Device

  IT WAS REPORTED BY THE PATIENT'S RELATIVE THAT THE 14 YEAR OLD PATIENT HAD ANKLE SURGERY (B)(6) 2020 USING AN ARTHREX INTERNAL ANKLE BRACE DURING THE BROSTRUM PROCEDURE. PATIENT IS EXPERIENCING SIGNIFICANT SWELLING, RASH, ETC. POST SURGERY. REPORTER IS SEEKING MATERIAL COMPOSITION OF THE DEVICE TO ASSIST IN DETERMINING IF PATIENT IS HAVING A POSSIBLE ALLERGIC REACTION TO THE ARTHREX DEVICE. ADDITIONAL INFORMATION OBTAINED 4/28/2020: IT IS REPORTED THAT THE PATIENT HAS HAD A ROUGH RECOVERY AND AN MRI SHOWED THAT THE INTERNAL BRACE WAS NOT PLACED CORRECTLY. PATIENT WILL REQUIRE A SECOND SURGERY WHICH HAS BEEN SCHEDULED FOR (B)(6) 2020 WITH A DIFFERENT SURGEON, AT A DIFFERENT FACILITY, TO ADDRESS THE INTERNAL BRACE AND POSSIBLE LIGAMENT ISSUES DUE TO THE PLACEMENT OF THE (B)(6) 2020 DEVICE. THE SURGEON PLANS TO OPEN THE WHOLE ANKLE, ADDRESS THE LIGAMENT ISSUES (WHICH THEY ARE UNSURE IF RELATED TO THE PLACEMENT OF THE BRACE OR ANOTHER ISSUE THE PATIENT MAY HAVE) AND SURGEON WILL ALSO CORRECT THE MISPLACEMENT OF THE INTERNAL BRACE, WITH PLANS TO REMOVE THE ORIGINAL DEVICE PLACED IN (B)(6) 2020. REPORTER DOES NOT KNOW WHAT MANUFACTURER PRODUCT THE SURGEON PLANS TO USE DURING THE SECOND P

  Patient problems: Rash; Swelling

  MAUDE report 10096356 ↗
• InjuryJan 27, 2020Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD AN ORIGINAL ANKLE PROCEDURE (B)(6) 2017. DURING THE SURGERY SIX ARTHREX PRODUCTS WERE IMPLANTED. THE PATIENT DEVELOPED ALLERGIC LIKE REACTION SYMPTOMS AND RECENTLY HAD TO UNDERGO A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT THE ARTHREX DEVICES. PATIENT DID NOT HAVE AN FURTHER DETAILS AT THE TIME OF REPORT BUT WILL PROVIDE SOON. ADDITIONAL INFORMATION 1/8/2020: ORIGINAL PROCEDURE WAS ON (B)(6) 2017 AND WAS A LEFT ANKLE ORIF. FOLLOWING SURGERY THE PATIENT WAS IN THE HOSPITAL FOR THREE NIGHTS. SHE STARTED HAVING RINGING IN HER EARS AND DIZZINESS 3 MONTHS AFTER SURGERY. THIS WAS FOLLOWED BY TIREDNESS, MIGRAINES, AND TMJ ON HER RIGHT SIDE. SHE ALSO DEVELOPED NOTICEABLY DRIER, FLAKY SKIN AND MORE ANXIETY AFTER ABOUT 6 MONTHS. SHE DEVELOPED FOOD INTOLERANCE TO DAIRY AND DEVELOPED A THYROID NODULE AS WELL. PATIENT HAD A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT ALL OF THE ORIGINAL IMPLANT DEVICES. THE SECOND SURGERY WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. THE FOLLOWING DEVICES WERE REPORTED TO HAVE BEEN IMPLANTED (B)(6) 2017 AND EXPLANTED (B)(6) 2019 (SPECIFIC ARTHREX PART NUMBERS WERE NOT PROVIDED): AR-8926SS, KNOTLESS TIGHTRO

  Patient problems: Anxiety; Cyst(s); Dizziness; Failure of Implant; Fatigue; Headache; Increased Sensitivity; Tinnitus

  MAUDE report 9631374 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY BROSTRUM REPAIR DONE ON (B)(6) 2018 IN WHICH THE AR-1688-CP INTERNALBRACE IMPLANT SYSTEM (LOT: 10224042) WAS USED. THE PATIENT WAS CLEARED BY THE SURGEON IN (B)(6) 2019 AFTER THE PROCEDURE. IN (B)(6) 2019 THE PATIENT RETURNED FOR A FOLLOW-UP, AND THE X-RAYS TAKEN REVEALED BONE LOSS AROUND THE SITE OF THE IMPLANTED ANCHORS. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019. THE REP STATED DURING THE REVISION PROCEDURE ALL IMPLANT COMPONENTS FROM THE AR-1688-CP SYSTEM WERE REMOVED FROM THE PATIENT WHOLE AND IN TACT. THE SURGEON TOOK CULTURES AND SAMPLES, AND REMOVED FLUID FROM THE ANKLE. THE CULTURE RESULTS REVEALED NO INFECTION FOUND. THE PATIENT DID NOT TEST POSITIVE FOR ANYTHING, AND THE CULTURE RESULTS ARE AVAILABLE. THE REP CONFIRMED THE PRIMARY AND REVISION PROCEDURE TOOK PLACE AT THE SAME FACILITY, AND WERE PERFORMED BY THE SAME SURGEON. ADDITIONAL INFORMATION RECEIVED ON 09/24/2019: THE REP STATED THEY WERE PRESENT FOR BOTH THE PRIMARY AND REVISION PROCEDURE. ARTHREX DEVICE AR-1688-CP (LOT: 10224042) WAS IMPLANTED DURING THE REVISION PROCEDURE. THE BONE QUALITY WAS MEDIUM, THE BONE WAS PREPPED PER THE TECHNIQUE GUIDE. THE SURGEON

  Patient problems: Osteopenia/ Osteoporosis

  MAUDE report 9141689 ↗
• InjuryJul 31, 2019Material Fragmentation

  IT WAS REPORTED DURING A PROCEDURE WHILE USING THE DRILL BIT WITHIN THE AR-1688-CP INTERNAL BRACE LIGAMENT IMPLANT SYSTEM, SHAVINGS WERE BEING PRODUCED FROM THE BIT. ADDITIONAL INFORMATION RECEIVED ON 07/11/2019: THE PROCEDURE TAKING PLACE WAS AN EVANS CALCANEAL OSTEOTOMY AND FDL TRANSFER WITH INTERNAL BRACE PROCEDURE. THE FACILITY REPORTER STATED 2MM SHAVINGS WERE COMING OFF OF THE DRILL BIT. THE SURGEON ATTEMPTED TO REMOVE ALL OF THE SHAVINGS, BUT THEY WERE VERY SMALL SO THE SURGEON IRRIGATED THE SHAVINGS OUT AS BEST AS POSSIBLE. A SECOND AR-1688CP WAS NOT OPENED, AND THE CASE WAS COMPLETED AS NORMAL. THE PROCEDURE WAS OPEN, AND UNPLANNED INCISION WAS NOT NECESSARY. THERE WAS AN ARTHREX SALES REPRESENTATIVE PRESENT DURING THE PROCEDURE. THE DEVICE WILL BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 07/17/2019: THE BONE WAS PREPPED BY USING A 2.7 CANNULATED DRILL. THE REP REPORTED THAT CASE PROCEEDED AS PLANNED WITH NO FURTHER ISSUES. THE SURGEON DID NOT EXPRESS ANY CONCERNS DURING OR AFTER THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8845617 ↗
• InjuryMay 13, 2019Break; Entrapment of Device

  IT WAS REPORTED THAT THE INTERNAL BRACE LIGAMENT, AR-1688-CP, WAS USED DURING A LATERAL ANKLE REPAIR WITH BROSTROM INTERNAL BRACE PROCEDURE. THE SURGEON WAS DRILLING THE HOLE FOR THE 4.75 ANCHOR IN THE TALUS. HE DECIDED HE WANTED TO DO THE K-WIRE FIRST TO MAKE SURE HE LIKED THE POSITION. DECIDED TO BREAK THE CORTEX WITH THE 2.7 CANNULATED DRILL AND WHEN HE DID SO, THE DRILL BROKE IN HALF IN THE PATIENTS BONE ALONG WITH THE K-WIRE. THE SURGEON WAS ABLE TO REAM OUT MOST OF THE DRILL BIT AND THE WIRE. HE THEN PROCEEDED WITH THE USUAL STEPS TO USE THE INTERNAL BRACE. THE PATIENT STILL HAS SOME OF THE DRILL PIECES LEFT IN THE TALUS AS HE WASN'T ABLE TO REMOVE ALL THE PIECES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8603507 ↗
• InjuryDec 12, 2018Break

  DURING A UCL INTERNAL BRACE PROCEDURE IT WAS REPORTED THE HANDLE ON THE DRILL GUIDE SNAPPED OFF THE GUIDE DURING DRILLING. THIS LEFT A PLASTIC TAB, WHICH WAS STILL SPINNING AND CUT A BRANCH OF THE ULNAR NERVE. A NEW KIT WAS THEN OPENED AND THE INTERNAL BRACE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THEN THE DOCTOR STITCHED THE NICK TO REPAIR THE BRANCH OF THE ULNAR NERVE. HE USED A 7-0 SIZE SUTURE FOR THE REPAIR. THE CASE WAS DELAYED APPROXIMATELY 20 MINUTES DUE TO THIS ISSUE. AT THIS TIME THE THERE IS NO CLINICAL PATIENT EFFECT FROM THE PROCEDURE. THE PATIENT WILL BE OBSERVED FOR THE NEXT FEW WEEKS TO SEE IF ANY DAMAGE TO THE NERVE WILL BE AN ISSUE.

  Patient problems: Nerve Damage

  MAUDE report 8155536 ↗
• InjuryOct 23, 2018Break

  IT WAS REPORTED THAT DURING A ATSL REPAIR PROCEDURE, THE SURGEON PREPPED THE BONE USING THE 3.4 DRILL, DRILL SLEEVE AND THE 4.75 TAP IN THE TALUS FOLLOWING THE CORRECT PROCEDURE. UPON INSERTING THE 4.75MM SWIVELOCK, THE ANCHOR BROKE IN HALF. HALF OF THE ANCHOR WAS RETRIEVED AND THE OTHER HALF OF THE ANCHOR REMAINED SECURELY IMPLANTED IN THE PATIENT. THE REP STATED THAT THE SURGEON FELT COMFORTABLE LEAVING THE REMAINING HALF OF THE ANCHOR IN THE PATIENT. THE REP CONFIRMED THAT THE CASE WAS COMPLETED WITHOUT ANY FURTHER ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 7994438 ↗
• InjuryJul 12, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INTERNAL BRACE AND BROSTROM REPAIR PROCEDURE ON (B)(6) 2017 WHERE AN AR-1688-CP, LOT: 10154871 AND TWO AR-1915FT¿S, LOT: 10160922 WERE IMPLANTED. THE PATIENT HEALED PROPERLY AFTER THE PROCEDURE, HOWEVER, THE INCISION TOOK A LONG TIME. A FEW MONTHS LATER, THE PATIENT BEGAN TO EXPERIENCE PAIN AND SWELLING AT THE INCISION SITE. SEVEN MONTHS POST-OP, ON (B)(6) 2018, THE PATIENT UNDERWENT A REVISION SURGERY WHERE THE INTERNAL BRACE AND BOTH CORKSCREW ANCHORS WERE REMOVED DUE THE PATIENT BEING ALLERGIC TO NICKEL. ADDITIONAL INFORMATION OBTAINED: BOTH PROCEDURES WERE PERFORMED AT THE SAME SURGERY CENTER BY THE SAME SURGEON. NO IMPLANTS REPLACED THE INTERNAL BRACE AND CORKSCREWS IN THE LATERAL ANKLE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling

  MAUDE report 7683215 ↗
• InjuryJun 14, 2018Material Fragmentation; Device Slipped; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF RIGHT CHRONIC LATERAL ANKLE SPRAINS. ON (B)(6) 2015 THE PATIENT UNDERWENT SURGERY TO REPAIR THE PERONEAL LONGUS AND BREVIS TENDONS. POSTOPERATIVELY, THE PATIENT WAS NONCOMPLIANT AND AMBULATING WITHOUT HER PRESCRIBED BOOT. SHE HAD RETURNED TO WEARING HER REGULAR SHOE AND TWISTED HER ANKLE. THIS RE-INJURY REQUIRED THE PATIENT TO UNDERGO A SECOND SURGERY. ON (B)(6) 2015, THE PATIENT UNDERWENT A BOSTROM GOULD-LIKE PROCEDURE WITH STABILIZATION OF THE LATERAL ANKLE LIGAMENTS UTILIZING TWO ARTHREX INTERNAL BRACES (AR-1688-CP LOT 1357160). THE OPERATIVE REPORT STATES THAT THE ANTERIOR TALOFIBULAR LIGAMENT WAS COMPLETELY TORN; TRANSECTION OF THE LIGAMENTS WAS THEN PERFORMED AND NEXT, USING STANDARD AO FIXATION TECHNIQUE, TWO INTERNAL BRACES WERE PLACED INTO THE FIBULA AS WELL AS TWO PORTIONS OF THIS WERE PLACED INTO THE TALUS. THE FIBERWIRE WAS THEN ANCHORED DOWN, WHICH WAS ASSOCIATED WITH THE INTERNAL ANKLE BRACE. THE ANKLE WAS SHOWN TO BE NOTABLY STABLE WITH NO LATERAL OR MEDIAL MOTION. THE MEDICAL RECORDS NOTE THAT THE PATIENT WAS NONAMBULATORY, ALTHOUGH THE CAST SHOWED NOTABLE BREAKDOWN ASSOCIATED TO THE PLANTAR ASPECT OF THE CAST. FOLLO

  Patient problems: Damage to Ligament(s); Failure of Implant; Injury; Pain

  MAUDE report 7600191 ↗
• InjuryMay 3, 2017Detachment Of Device Component

  IT WAS REPORTED THAT DURING AN FDL TRANSFER IN CONJUNCTION WITH THE INTERNAL BRACE FOR SPRING LIGAMENT, THE SURGEON WAS USING AN INTERNAL BRACE LIGAMENT KIT. UPON IMPLANTING THE 3.5 MM SWIVELOCK FROM THE INTERNAL BRACE KIT, THE DRIVER DISCONNECTED BEFORE THE ANCHOR WAS FULLY SEATED; LEAVING 1-2 THREADS PROUD. THE PROUD PORTION OF THE ANCHOR WAS REMOVED WITH A RONGEUR AND THE CASE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6539931 ↗
• InjuryOct 12, 2016Patient-Device Incompatibility

  IT WAS REPORTED THAT PATIENT HAD PREVIOUSLY CONTACTED ARTHREX PRIOR TO A PLANNED SURGERY TO OBTAIN THE MATERIAL COMPOSITION OF THE AR-1688-CP WHICH WAS PROVIDED TO HER. THE ARTHREX RECORD REFERENCE NUMBER FOR THIS INQUIRY WAS CC94565. PATIENT HAS NOW REPORTED THAT SHE HAD UNDERGONE RIGHT HALLUX VARUS CORRECTION SURGERY ON (B)(6) 2016. PATIENT WAS UNABLE TO LOCATE ANY ALLERGIST OR DERMATOLOGIST WHO WAS ABLE TO DO TESTING FOR THE BOVINE COLLAGEN COATED FIBERTAPE USED IN THE AR-1688-CP AND CHOSE TO PROCEED WITH THE SURGERY WITHOUT ALLERGY TESTING. PATIENT REPORTS THAT BEGINNING TWO WEEKS POST-OP, SHE WAS EXPERIENCING HIVES WITH SINGLE HIVES APPEARING PRIOR TO TWO WEEKS POST-OP. PATIENT REPORTS THAT THE HIVES ARE NOW ON HER LEGS, THIGH, CHEST, BACK AND ELSEWHERE. IN ADDITION, PATIENT REPORTS THAT AFTER THE WRAPPING AND SUTURES CAME OUT TWO WEEKS POST-OP HER BIG TOE WAS ANGLED OUTWARDLY IN THE SAME WAY AS IT DID PRIOR TO SURGERY. PATIENT STATES THE SURGEON DID NOT EXPLAIN WHY THE PROCEDURE DID NOT WORK AND ONLY INDICATED TO HER THAT IT WAS UNFORTUNATE. ADDITIONAL INFORMATION OBTAINED 10/12/2016: PATIENT HAS PROVIDED AN UPDATE AND HAS REPORTED THAT HER HIVES ARE NOW GONE. SHE HAD SCHEDUL

  Patient problems: Urticaria

  MAUDE report 6021291 ↗