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Arthrex® AR-8690DSRecalls & reported problems

Arthrex, Inc. · IMPLANT SYSTEM, CPR MINI SCORPION DX · Class 2 · Implant

Quick summary

This Arthrex CPR Mini Scorpion DX implant system is used to pass surgical sutures during repairs. The 26 reports mostly describe sutures or wires failing to advance, parts sticking or breaking, and components not fitting together. Reports include 22 malfunctions, 4 injuries, and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
26
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888867044692), received between Nov 7, 2016 and Oct 20, 2025 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 2 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 1 reportsApr 2024: 7 reportsMay 2024: 2 reportsJun 2024: 6 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Advance6
  • Break4
  • Physical Resistance/Sticking4
  • Defective Device2
  • Mechanical Problem2
  • Adverse Event Without Identified Device or Use Problem1
  • Connection Problem1
  • Detachment Of Device Component1

Patient problems

  • No Clinical Signs, Symptoms or Conditions12
  • Insufficient Information10
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Nerve Damage1
  • No Consequences Or Impact To Patient1
  • Pain1

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 20, 2025Break; Break

    ON 10/02/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8690DS CPR MINI SCORPION DX IMPLANT SYSTEM HAD AN ISSUE WITH THE MINI SCORPION NEEDLE BREAKING WHILE PASSING THE SUTURE. ALL BROKEN PIECES WERE RETRIEVED WITHOUT ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED ON 10/06/2025: ON (B)(6) 20225, DURING A PLANTAR PLATE REPAIR PROCEDURE, THE NEEDLE AND SHAFT BROKE INSIDE THE PATIENT WHILE MAKING THE SECOND PASS FOR THE SUTURE. THE BROKEN COMPONENTS WERE IMMEDIATELY VISUALIZED AND SUCCESSFULLY REMOVED. THIS INCIDENT TOOK PLACE PRIOR TO THE INSERTION OF ANY IMPLANT. THE BONE QUALITY WAS ASSESSED AS GOOD. THE PROCEDURE WAS COMPLETED USING THE PIGTAIL LASSOS INCLUDED IN THE KIT. THERE WAS NO CASE DELAY, NO ADDITIONAL ANESTHESIA ADMINISTERED, AND NO ADVERSE EFFECTS REPORTED DURING OR FOLLOWING THE SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23335445 ↗
  • MalfunctionJun 20, 2024Failure to Advance; Failure to Advance

    ON 5/20/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE MICRO SUTURELASSO FROM AN AR-8690DS IMPLANT KIT, WOULD NOT ADVANCE THROUGH THE CURVE. ALSO, ON THE SHORT BONE TUNNEL LASSOS, ONE OF THE GREEN FUNNEL WAS MISSING. ANOTHER KIT WAS OPENED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

    Patient problems: Insufficient Information

    MAUDE report 19574233 ↗
  • MalfunctionJun 19, 2024Failure to Advance; Failure to Advance

    ON 4/17/2032, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-8690DS LEFT GREEN PIGTAIL WOULD NOT ALLOW THE SUTURE TO PASS THROUGH. THE SURGEON WAS ABLE TO USE THE RED RIGHT PIG TAIL. THIS WAS DISCOVERED DURING A PROCEDURE A WEIL OSTEOTOMY ON 4/14/2023. THE CASE WAS DELAYED TEN TO TWELVE MINUTES; HOWEVER, THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19570610 ↗
  • MalfunctionJun 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE 2MM BY 11MM QUICKFIX SCREW FROM AN AR-8690DS CPR IMPLANT SYSTEM WOULD NOT FIT INTO THE PIN DRIVER. THE SHAFT OF THE SCREW APPEARED TO BE TOO WIDE. AFTER NUMEROUS ATTEMPTS, THE SURGEON REQUESTED ANOTHER PIN DRIVER, BUT THE SCREW WOULDN¿T FIT EITHER. A SECOND CPR KIT WAS OPENED, AND THE 2.0MM X11MM SCREW WAS IMPLANTED SUCCESSFULLY. THIS WAS DISCOVERED DURING A COMPLETE PLANTAR PLATE REPAIR PROCEDURE ON (B)(6) 2023.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19563471 ↗
  • MalfunctionJun 13, 2024Mechanical Jam; Mechanical Jam

    ON 08/09/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT A AR-8690DS CPR MINI SCORPIONS PIGTAIL LASSOS ARE NOT ALLOWING WIRE TO ADVANCE. THIS OCCURRED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19533214 ↗
  • MalfunctionJun 13, 2024Mechanical Problem; Mechanical Problem

    ON 4/26/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT THE GREEN AND REG PIGTAIL SUTURE PASSERS FROM AN AR-8690DS, CPR MINI SCORPION DX IMPLANT SYSTEM WOULD NOT THREAD THE SUTURES THROUGH. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19532116 ↗
  • MalfunctionJun 12, 2024Mechanical Problem; Mechanical Problem

    IT WAS REPORTED THAT THE RIGHT CURVED RED HANDLED MICRO SUTURE LASSO WITHIN THE AR-8690DS IMPLANT SYSTEM, HAD SOME SORT OF BLOCKAGE IN THE CANNULA TOON WHICH PREVENTED ADVANCEMENT OF THE WIRE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19525349 ↗
  • MalfunctionMay 6, 2024Failure to Advance; Failure to Advance

    IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8690DS PIGTAIL PASSERS ARE GETTING STUCK WHILE PASSING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19254121 ↗
  • MalfunctionMay 3, 2024Failure to Advance; Failure to Advance

    IT WAS REPORTED ON 09/21/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8690DS PIGTAIL PASSERS ARE GETTING STUCK WHILE PASSING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Patient problems: Insufficient Information

    MAUDE report 19238302 ↗
  • MalfunctionApr 26, 2024Defective Device; Defective Device

    IT WAS REPORTED ON 09/14/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8690DS IMPLANT SYSTEM NTINOL WIRE WOULD NOT PASS THROUGH THE PIGTAIL LASSOS. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19195564 ↗
  • MalfunctionApr 25, 2024Defective Device; Defective Device

    ON 11/23/2021, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT A AR-8690DS IMPLANT SYSTEM IS DEFECTIVE. THE PIGTAILED LASSOS WERE DEFECTIVE. THE WIRES WERE UNABLE TO BE PASSED THROUGH THE CANNULATION. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED ON 11/24/2021 : THE CASE WAS COMPLETED USING A SECOND SET THAT WAS OPENED AND THE SUTURE PASSERS WERE OPERATING PROPERLY

    Patient problems: Insufficient Information

    MAUDE report 19182079 ↗
  • MalfunctionApr 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

    ON 4/11/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8690DS PR MINI SCORPION, DX AND MICRO SUTURELASSO IMPLANT SYSTEM HAD A COUPLE OF ISSUE. THE MICRO SUTURELASSO CANNULATION WOULD NOT ALLOW THE NITINOL WIRE TO BE PASSED AND THE DX MINI SCORPION NEEDLE BROKE DURING USE, ALL BROKEN FRAGMENTS WERE RETRIEVED. SURGEON OPENED ANOTHER AR-8690DS KIT, AND THE MICRO SUTURELASSO ALSO DID NOT ALLOW THE NITINOL WIRE TO PASS THROUGH. THIS WAS DISCOVERED DURING A CPR, COMPLETE PLANTER PLATE REPAIR, PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY AND NO FURTHER HAS BEEN REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 19173158 ↗
  • MalfunctionApr 16, 2024Failure to Advance; Failure to Advance

    ON 2/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE NITINOL WIRE FROM AN AR-8690DS CPR MINI SCORPION DX AND MICRO SUTURELASSO IMPLANT SYSTEM WOULD NOT GO THROUGH ONE OF THE SUTURELASSO. SURGEON WAS ABLE TO COMPLETE THE CASE USING THE OTHER SUTURELASSO FROM THE KIT. THIS WAS DISCOVERED DURING A PLANTAR PLATE REPAIR PROCEDURE ON (B)(6) 2023. CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY FURTHER ISSUES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19118222 ↗
  • MalfunctionApr 16, 2024Difficult to Advance; Difficult to Advance

    ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE NITINOL WIRE FROM BOTH OF MICRO SUTURE LASSO FROM AN AR-8990DS CPR MINI SCORPION DX AND MICRO SUTURE LASSO IMPLANT SYSTEM, WOULD GET JAMMED AND NOT EXTEND AS IT SHOULD. SURGEON USED STERILE MINERAL OIL TO HELP LUBRICATE THE LASSO AND WAS ABLE TO COMPLETE THE CASE WITH THE KIT. THIS WAS DISCOVERED DURING A PLANTAR PLATE REPAIR PROCEDURE ON (B)(6) 2022.

    Patient problems: Insufficient Information

    MAUDE report 19117508 ↗
  • MalfunctionApr 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8690DS KIT WAS OPENED DURING A CASE AND ATTEMPTED A PIGTAIL WIRE AND THE LASSO WAS GETTING STUCK. THIS WAS DISCOVERED DURING A CASE AND WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19099822 ↗
  • MalfunctionApr 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

    IT WAS REPORTED ON 06/22/2022 BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-8690DS MINI-SCORPION NITINOL WIRE IS STICKING. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. PER FACILITY: "DR. (B)(6) HAS BEEN USING ARTHREX FOR HER PLANTAR PLATE REPAIRS FOR OVER 5 YEARS. SHE HAS ALWAYS USED AND LOVED THE RED AND GREEN LASSOS THAT COME IN THE KIT INSTEAD OF USING THE SCORPION. SHE HAS NEVER HAD A PROBLEM WITH THEM UNTIL RECENTLY. I HAVE HAD 3 CASES WITH DR. (B)(6) IN THE LAST TWO MONTHS WHERE THE NITINOL WIRE THAT IS IN THE LASSOS WILL NOT COME OUT OF THE TIP OF THE LASSO AFTER PULLING IT BACK BEFORE PASSING THROUGH THE PLANTAR PLATE. FIRST TWO TIMES THIS HAPPENED, IT ONLY HAPPENED WITH THE RED LASSO. SO, WE JUST TOOK THE NITINOL WIRE OUT OF THE GREEN LASSO AND PUT IT IN THE RED ONE AND SEEMED TO WORK FINE. BUT SHE STILL WASN¿T HAPPY. WE ALSO COULDN¿T UNDERSTAND WHY ONE NITINOL WIRE WORKED AND THE OTHER ONE DIDN¿T, CONSIDERING THEY ARE BOTH THE SAME THING. THE THIRD TIME WAS BY FAR THE WORST/MOST EMBARRASSING MOMENT I HAVE EVER BEEN IN WITH OUR PRODUCT. NEITHER LASSO WOULD WORK. WE TRIED EVERYTHING. SQUIRTING SALINE IN THE LASSO, GETTING THE NITINOL WIRE WET THINKING IT WOU

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19087285 ↗
  • MalfunctionMar 29, 2024Failure to Advance; Failure to Advance

    ON 4/13/2022 IT WAS REPORTED, BY A SALES REPRESENTATIVE VIA EMAIL, THAT THE PIGTAIL PASSERS FROM AR-8690DS IMPLANT SYSTEM WIRES WOULD NOT ADVANCE PAST THE CURVE OF THE PIGTAIL. SURGEON OPENED A VIPER AND WAS USED TO CONTINUE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE.

    Patient problems: Insufficient Information

    MAUDE report 19008337 ↗
  • MalfunctionFeb 12, 2024Break; Break

    ON 01/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8690DS IMPLANT SYSTEMS TIP OF THE SCORPION NEEDLE WOULDN¿T PIERCE THROUGH THE TISSUE. THIS OCCURRED DURING A PLANTAR PLATE REPAIR ON (B)(6) 2024, WHERE THEY OPENED THE KIT AND ATTEMPTED TO USE THE DX MINI SCORPION. UPON DEPLOYING THE NEEDLE FROM THE KIT THROUGH THE DEVICE, THE TIP OF THE SCORPION NEEDLE WOULDN¿T PIERCE THROUGH THE TISSUE. IT APPEARED TO HAVE BROKEN OFF/BENT OFF. THE CASE CONTINUED USING OTHER ITEMS IN THE KIT TO REPAIR THE PLANTAR PLATE. NO DAMAGE OR HARM WAS CAUSED TO THE PATIENT. IT DID ADD SOME EXTRA TIME TO THE CASE AS THE SURGEON HAD A MORE CHALLENGING TIME USING THE PIGTAILS FROM THE KIT, BUT HE ENDED UP COMPLETING THE REPAIR IN AN AVERAGE AMOUNT OF TIME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18685517 ↗
  • MalfunctionNov 20, 2023Break; Break

    ADDITIONAL INFORMATION WAS PROVIDED ON 10/31/2023, WHERE THE SALES REPRESENTATIVE REPORTED THAT THIS EVENT OCCURRED DURING A PLANTAR PLATE ON (B)(6) 2023. IT WAS NOTED THAT THE NEEDLE MAY HAVE MALFUNCTIONED OR GOT CAUGHT UP IN TISSUE/SUTURE RESULTING IN IT BREAKING. THEY ARE NOT SURE IF THE FRAGMENTS WERE FULLY RETRIEVED.

    Patient problems: Insufficient Information

    MAUDE report 18170705 ↗
  • MalfunctionNov 9, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    ON 10/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE PIGTAIL LASSOS FROM AN AR-8690DS CPR MINI SCORPION DX AND MICRO SUTURE LASSO IMPLANT SYSTEM, WOULD NOT PASS THROUGH THE SHARP END. THE CANNULATION AT THE END WAS NOT LARGE ENOUGH. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-8690DS CPR MINI SCORPION DX AND MICRO SUTURE LASSO IMPLANT SYSTEM. THIS WAS DISCOVERED DURING AN CPR PLANTAR PLATE PROCEDURE ON (B)(6) 2023.

    Patient problems: Insufficient Information

    MAUDE report 18103824 ↗
  • MalfunctionMay 30, 2023Break; Break

    ON 5/5/2023, A MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL, REPORTED BY A FACILITY REPRESENTATIVE THAT A SMALL PIECE OF METAL FROM AN AR-8690DS CPR MINI SCORPION DX AND MICRO SUTURELASSO IMPLANT SYSTEM BROKE OFF. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 17024761 ↗
  • MalfunctionMay 3, 2022Output Problem

    ON 4/11/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8690DS PR MINI SCORPION, DX AND MICRO SUTURELASSO IMPLANT SYSTEM HAD A COUPLE OF ISSUE. THE MICRO SUTURELASSO CANNULATION WOULD NOT ALLOW THE NITINOL WIRE TO BE PASSED AND THE DX MINI SCORPION NEEDLE BROKE DURING USE, ALL BROKEN FRAGMENTS WERE RETRIEVED. SURGEON OPENED ANOTHER AR-8690DS KIT, AND THE MICRO SUTURELASSO ALSO DID NOT ALLOW THE NITINOL WIRE TO PASS THROUGH. THIS WAS DISCOVERED DURING A CPR, COMPLETE PLANTER PLATE REPAIR, PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY AND NO FURTHER HAS BEEN REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 14269407 ↗
  • InjuryNov 30, 2021Device Slipped; Connection Problem

    IT WAS REPORTED THAT THE SURGERY STARTED WITH THE WEIL¿S OSTEOTOMY, THEN THE PLANTAR PLATE REPAIR. THIS ALL WENT SMOOTHLY. THEN THE SURGEON ISOLATED THE EDB TENDON AND DRILLED 2 X 2.5MM HOLES USING THE MINI BIOTENODESIS DISPOSABLES SET AR-1530DS, HE THEN INSERTED A 3X8MM BIOTENODESIS SCREW (AR-1530BC) IN THE PROXIMAL HOLE WHICH WENT FINE. THE SURGEON THEN TRIED TO INSERT THE SECOND SCREW IN USING AN IDENTICAL PRODUCT BUT THE SCREW WOULD NOT ENGAGE WITH THE TENDON AND HOLE. WHEN HE HAD INSERTED IT AND TRIED TO DISENGAGE THE SCREW DRIVER, THE SCREW CAME OUT WITH THE SCREW DRIVER. HE TRIED THIS A COUPLE MORE TIMES UNTIL IT FINALLY WORKED. HOWEVER IT WAS SLIGHTLY PROMINENT, HE WENT TO TIGHTEN IT AND THE SCREW CAME OUT AGAIN. HE HAD BY THIS POINT TRIMMED THE TAPE AND SUTURE ON THE END OF THE TENDON SO WAS UNABLE TO TENSION AGAIN TO FINISH THAT ASPECT OF THE PROCEDURE. THE REPORTED EVENT WAS A 1ST MTP DISTAL PHALANX WHICH IS A SMALL PIECE OF BONE. THEN THE SURGEON TRIED TO INSERT THE QUICK FIX SCREW FROM THE CPR SET. HOWEVER THE QUICK FIX SCREW DID NOT SNAP OFF. AFTER MULTIPLE ATTEMPTS AT INSERTING A TWIST OFF SCREW AFTER A WEIL¿S OSTEOTOMY THE BONE WASN¿T IN GOOD CONDITION ANYMORE. THE

    Patient problems: Pain

    MAUDE report 12895187 ↗
  • InjuryMay 10, 2021Difficult to Remove; Therapeutic or Diagnostic Output Failure

    IT WAS REPORTED THAT THE QUICKFIX SNAP-OFF SCREWS WERE DIFFICULT TO SNAP OFF WITH THE K-WIRE DRIVER DURING A WEIL OSTEOTOMY PROCEDURE. THE FIRST SCREW (GREEN 2X13 MM) WAS DRIVEN IN WITH THE K-WIRE AND PRESENTED DIFFICULTY BUT DID SNAP-OFF. THE SECOND SCREW (PINK 2X11 MM) FAILED TO SNAP-OFF WHEN DRIVEN IN WITH THE K-WIRE DRIVER. THE K-WIRE DRIVER WAS REMOVED AND A HAND SCREWDRIVER WAS USED TO BACK OUT THE SCREW A FEW TURNS THEN ATTEMPT RE-INSERTION. WHEN THE SCREW HEAD CONTACTED THE NEAR-CORTEX, IT STILL FAILED TO SNAP-OFF. ADDITIONAL FORCE WAS APPLIED MANUALLY IN ORDER TO BEND THE WIRE INSERTION PORTION OF THE SCREW WHICH CAUSED CRACKING OF THE PATIENT¿S BONE. THE SURGERY WAS COMPLETED BY REMOVING THE SCREW MANUALLY, REPOSITIONING THE OSTEOTOMY, MANUALLY INSERTING THE SCREW WITH A .045 PILOT HOLE, AND MANUALLY SNAPPING THE SCREW OFF WITH A NEEDLE DRIVER AND HAND DRIVER. AN ADDITIONAL .045 K-WIRE AND #0 VICRYL IN A CERCLAGE-LIKE FASHION WERE USED FOR ADDITIONAL FIXATION.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 11801459 ↗
  • InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem

    THE PATIENT HAS PROVIDED THE FOLLOWING INFORMATION: PATIENT HAD UNDERGONE A LEFT FOOT OSTEOTOMY METATARSAL/LEFT WEIL PLANTAR PLATE REPAIR ON (B)(6) 2017. DURING THE PROCEDURE, AN ARTHREX ACP INJECTION SYSTEM (ACP KIT SERIES II, ABS-10012, LOT 616565204, QTY 2) WAS UTILIZED AND 2 ARTHREX QUICK FIX SCREWS WERE IMPLANTED (AR-8930-11, LOT 10111019). THE FOLLOWING ARTHREX PRODUCTS WERE ALSO USE: AR-13930DS (LOT 703771055) MENISCAL VIPER REPAIR KIT AND AR-8690DS (LOT 10091584, QTY 2) IMPLANT SYSTEM, CPR MINI SCORPION DX. AFTER THE LOCAL ANESTHETIC WORE OFF HIS LEFT FOOT FELT LIKE IT WAS ASLEEP AND THE FEELING RADIATED TO JUST ABOVE THE ANKLE BONE. FEELING HAS NOT GONE AWAY SINCE THE SURGERY. CONDITION DOES NOT IMPACT ANY ACTIVITY, EXCEPT IT FEELS STRANGE, OFTEN A DEAD FEELING AND COLD. ONLY EXCEPTION TO FUNCTIONALITY IS PATIENT'S BALANCE WHILE STANDING ON HIS LEFT FOOT ONLY IS SLIGHTLY WORSE THAN THEN STANDING ON HIS RIGHT FOOT. PATIENT HAD REACHED OUT TO THE SURGEON IN EARLY 2019 BUT CHOSE TO FOLLOW UP WITH HIS LOCAL PHYSICIAN WHO REFERRED HIM FOR REVIEW BY A NEUROLOGIST. EMG EXAM WAS CONDUCTED AND MRI'S WERE PERFORMED ON THE LEFT KNEE AND ANKLE. PATIENT RECAP OF TESTING RESULTS: EMG SH

    Patient problems: Nerve Damage

    MAUDE report 9580151 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.