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Arthrex® AR-8919DSRecalls & reported problems

Arthrex, Inc. · IMPL SYS,CMC MINI T-ROPE,1.1 MM · Class 2

Quick summary

This Arthrex CMC Mini Tightrope implant is a small suture-button system used to stabilize the base of the thumb. The 27 reports mostly describe the device breaking during surgery — wires, loops or the button separating or splitting — so fragments had to be removed, plus patients reporting ongoing thumb pain, discomfort and skin discoloration afterward. There were 9 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
27
Deaths reported
0
Injuries reported
9
Recalls naming it
0

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888867048966), received between Oct 4, 2016 and Jan 20, 2026 — classified as 9 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (12 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: 0 reportsDec 2023: 1 reportsJan 2024: 2 reportsFeb 2024: 3 reportsMar 2024: 2 reportsApr 2024: 1 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 1 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 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break12
  • Patient Device Interaction Problem5
  • Material Split, Cut or Torn3
  • Adverse Event Without Identified Device or Use Problem2
  • Fracture1
  • Insufficient Device Problem Information1
  • Manufacturing, Packaging or Shipping Problem1
  • Material Protrusion/Extrusion1

Patient problems

  • No Clinical Signs, Symptoms or Conditions10
  • Pain8
  • Insufficient Information6
  • Reaction2
  • Complex regional pain syndrome1
  • Discomfort1
  • Edema1
  • Failure of Implant1

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 20, 2026Patient Device Interaction Problem

    ON 05-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT A PATIENT UNDERWENT A CMC PROCEDURE ON (B)(6) 2025 DURING WHICH AN AR-8919DS CMC MINI TIGHTROPE IMPLANT SYSTEM WAS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT INTRAOPERATIVE COMPLICATIONS. AT THE FOLLOW-UP VISIT ON (B)(6) 2026, THE PATIENT REPORTED PERSISTENT DISCOMFORT AND PAIN WITH LIMITED RECOVERY PROGRESS. NO ADDITIONAL DETAILS REGARDING IMAGING, TREATMENT PLAN, OR FURTHER CLINICAL EVALUATION WERE PROVIDED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 07-JAN-2026: THE PATIENT REPORTED BEING CONCERNED ABOUT EXPERIENCING SWELLING A MONTH OUT FROM SURGERY. NO ADDITIONAL DETAILS REGARDING IMAGING, TREATMENT PLAN, OR FURTHER CLINICAL EVALUATION WERE PROVIDED AT THIS TIME.

    Patient problems: Discomfort; Pain; Swelling/ Edema

    MAUDE report 24114541 ↗
  • MalfunctionDec 9, 2025Break; Break

    ON 11/21/2025, AN FDA MEDSUN NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT ONE OF THE K-WIRE LOOPS FROM AN AR-8919DS CMC MINI TIGHTROPE IMPLANT SYSTEM BROKE. THE BROKEN LOOP PIECE WAS RETRIEVED. THIS INCIDENT WAS DISCOVERED IN A PROCEDURE IN (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 12/02/2025: THIS OCCURRED ON (B)(6) 2025.

    Patient problems: Insufficient Information

    MAUDE report 23759099 ↗
  • MalfunctionDec 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

    ON (B)(6) 2025, A PATIENT CALLED IN AN AND REPORTED THAT SHE EXPERIENCED PAIN AFTER UNDERGOING A PROCEDURE WHERE AN AR-8919DS IMPLANT SYSTEM WAS IMPLANTED. THE PATIENT UNDERWENT A PROCEDURE ON HER RIGHT HAND IN (B)(6) OF 2023. FOR THE LAST YEAR, THE PATIENT STATED SHE HAS EXPERIENCED PAIN, SENSITIVITY TO TEMPERATURE IN HER INDEX FINGER, AND NUMBNESS.

    Patient problems: Hyperresponsive to stimuli; Numbness; Pain

    MAUDE report 23703649 ↗
  • MalfunctionAug 6, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

    ON 17TH JULY 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT FOR AN AR-8919DS, IMPLANT SYSTEM, CMC MINI TIGHTROPE, 1.1 MM, DURING THE FINAL FIXATION OF DRUJ, IT WAS FOUND THAT THE BUTTON WAS NOT ATTACHED ON THE CORTICAL BONE PROPERLY. THE SURGEON FOUND THE SUTURE WAS BROKEN. THIS WAS DETECTED DURING USE IN AN OPEN REDUCTION INTERNAL FIXATION OF DISTAL RADIUS ULNAR JOINT PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ADDITIONAL MINI TIGHTROPE.

    Patient problems: Insufficient Information

    MAUDE report 22727084 ↗
  • InjuryJul 30, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

    ADDITIONAL INFORMATION WAS RECEIVED ON 08/05/2025: THE PATIENT IS APPROXIMATELY FOUR MONTHS POST-OPERATIVE AND CONTINUES TO EXPERIENCE PERSISTENT PAIN AT THE BASE OF THE THUMB. THE THUMB FREQUENTLY CREAKS AND CRACKS WITH MOVEMENT, OFTEN CAUSING NIGHTTIME PAIN THAT DISRUPTS SLEEP. THE PATIENT HAS ALSO NOTED OCCASIONAL SKIN DISCOLORATION, APPEARING BLACK AND BLUE. PHYSICAL THERAPY HAS PROVEN INEFFECTIVE AND IRRITATES THE WRIST. DESPITE THE SURGEON¿S ASSESSMENT THAT EVERYTHING APPEARS NORMAL, THE PATIENT REPORTS THAT SYMPTOMS ARE NOW WORSE THAN PRIOR TO SURGERY.

    Patient problems: Complex regional pain syndrome; Limb Pain; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Skin Discoloration; Sleep Dysfunction

    MAUDE report 22665985 ↗
  • MalfunctionMay 8, 2025Break; Break

    ADDITIONAL INFORMATION RECEIVED ON 5/7/2025: BEFORE THE PATIENT WAS CLOSED UP, ALL THE BROKEN FRAGMENTS FROM THE NITINOL LOOPS WERE REMOVED.

    Patient problems: Insufficient Information

    MAUDE report 21984205 ↗
  • MalfunctionMar 10, 2025Break; Break

    ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT THE FIBERWIRE FROM AN AR-8919DS CMC MINI TIGHTROPE IMPLANT SYSTEM BROKE DURING LIGATION. THE CASE WAS COMPLETED USING ANOTHER AR-8919DS CMC MINI TIGHTROPE IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 2/27/2025: THIS WAS DISCOVERED DURING A CMC PROCEDURE. THE ANCHOR AND ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21559520 ↗
  • MalfunctionFeb 24, 2025Break; Break

    ON 02/12/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-8919DS CMC MINI TIGHTROPE IMPLANT SYSTEM THREADS FELT LOOSE WHEN LIGATING, AND USE WAS DISCONTINUED DUE TO CONCERNS ABOUT THREAD BREAKAGE. THE CASE WAS COMPLETED BY USING ANOTHER OF THE SAME PRODUCT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 02/18/2025: THIS OCCURRED INSIDE THE PATIENT. ALL LOOSE THREAD WERE REMOVED FROM THE PATIENT. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED. THIS WAS DISCOVERED DURING A CMC PROCEDURE ON (B)(6) 2025.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21449029 ↗
  • MalfunctionMay 6, 2024Break; Break

    ON 4/8/2024, IT WAS REPORTED BY A FACILITY RISK MANAGER VIA AN FDA MAUDE REVIEW EMAIL THAT THE GUIDEWIRE FROM AN AR-8919DS CMC MINI TIGHTROPE IMPLANT SYSTEM BROKE DURING INSERTION. THE SURGEON ATTEMPTED TO RETRIEVE THE BROKEN FRAGMENT WITH A HEMOSTAT; HOWEVER, IT BENT. THE FRAGMENT WAS SUCCESSFULLY REMOVED USING A NEEDLE DRIVER. AN X-RAY CONFIRMED ALL THE FRAGMENTS WERE REMOVED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/15/2024: THE MEDWATCH NOTIFICATION REPORTS THAT AFTER THE HEMOSTAT BENT, A NEEDLE DRIVER WAS USED TO RETRIEVE THE BROKEN GUIDEWIRE. HOWEVER, WHEN THE NEEDLE DRIVER WAS REMOVED FROM THE PATIENT, IT WAS NOTICED THAT THE TIP HAD BROKEN OFF. A MINI-C-ARM X-RAY WAS TAKEN, WHICH SHOWED THE TIP INSIDE THE PATIENT. A PORTABLE X-RAY WAS PERFORMED TO ENSURE THAT NOTHING WAS RETAINED. THE PORTABLE X-RAY WAS DEEMED NEGATIVE BY THE DOCTOR. THE CASE WAS COMPLETED, AND NO FOLLOW-UP CARE WAS NEEDED FOR THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 4/22/2024: THE PORTABLE X-RAY CONFIRMED THAT THE BROKEN TIP WAS NEVER IN THE PATIENT. ADDITIONAL INFORMATION REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 19249585 ↗
  • MalfunctionApr 24, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED ON 08/09/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8919DS SUTURE BUTTONS WERE DIFFERENT METALS, ONE TITANIUM AND ONE STAINLESS STEEL. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19174879 ↗
  • MalfunctionMar 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    IT WAS REPORTED THAT THE LOOP OF THE DEVICE CAME LOOSE DURING INSERTION. NO PART OF THE DEVICE BROKE INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 31-MAR-2021: IT WAS CONFIRMED THAT THE DEVICE TORE OUTSIDE OF THE PATIENT AND NOTHING BROKE INSIDE OF THE PATIENT. NO PATIENT WAS HARMED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18956189 ↗
  • MalfunctionMar 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

    ON 02/22/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-8919DS CMC MINI TIGHTROPE SUTURE SNAPPED WHILE BEING TENSIONED. CASE COMPLETED USING ANOTHER TIGHTROPE. DELAY IN CASE 40 MINUTES. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18887631 ↗
  • MalfunctionFeb 15, 2024Break; Break

    ON 01/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8919DS MINI TIGHTROPE CRIMP HOLDING THE WIRE BROKE WHEN USING SHORT PASSING WIRE TO PULL TIGHTROPE THROUGH TUNNEL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18711177 ↗
  • MalfunctionFeb 15, 2024Break; Break

    ON 01/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8919DS MINI TIGHTROPE CRIMP HOLDING THE WIRE BROKE WHEN USING SHORT PASSING WIRE TO PULL TIGHTROPE THROUGH TUNNEL. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18711154 ↗
  • MalfunctionFeb 5, 2024Unsealed Device Packaging; Unsealed Device Packaging

    ON (B)(6) 2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8919DS TIGHTROPE IMPLANT SYSTEM STERILE PACKAGING WAS NOT COMPLETELY SEALED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. SURGEON USED A NEW PRODUCT TO COMPLETE CASE SUCCESSFULLY AND THE PATIENT WAS NOT AFFECTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18641344 ↗
  • MalfunctionJan 8, 2024Break; Break

    ON 4/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-8919DS CMC MINI TIGHTROPE SUTURE BROKE WHILE TRYING TO PASS THROUGH THE TUNNELS. THE CASE WAS COMPLETED USING ANOTHER AR-8919DS CMC MINI TIGHTROPE. THIS WAS DISCOVERED DURING A CMC ARTHROPLASTY PROCEDURE ON (B)(6) /2023.

    Patient problems: Insufficient Information

    MAUDE report 18466728 ↗
  • MalfunctionJan 8, 2024Break; Break

    ON 4/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (2) AR-8919DS CMC MINI TIGHTROPE SUTURE BROKE WHILE TRYING TO PASS THROUGH THE TUNNELS. THE CASE WAS COMPLETED USING ANOTHER AR-8919DS CMC MINI TIGHTROPE. THIS WAS DISCOVERED DURING A CMC ARTHROPLASTY PROCEDURE ON (B)(6) 2023.

    Patient problems: Insufficient Information

    MAUDE report 18466649 ↗
  • InjuryDec 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

    ON 11/16/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT ON (B)(6) 2023, A PATIENT UNDERWENT A PROCEDURE WHERE AN AR-8919DS IMPLANT SYSTEM WAS USED WHICH RESULTED IN AN INFECTION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Unspecified Infection

    MAUDE report 18340875 ↗
  • InjuryOct 20, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

    ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT A PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2023 IN WHICH AN AR-8919DS CMC MINI TIGHTROPE IMPLANT SYSTEM WAS IMPLANTED. THE PATIENT HAS COMPLAINED OF PAIN AND IS GETTING TESTED FOR AN ALLERGIC REACTION. THERE ARE NO PHYSICAL SYMPTOMS OF AN ALLERGIC REACTION AT THIS TIME. NO FURTHER INFORMATION WAS REPORTED.

    Patient problems: Hypersensitivity/Allergic reaction; Pain

    MAUDE report 17977208 ↗
  • MalfunctionMay 31, 2022Break

    ON (B)(6) 2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-8919DS CMC MINI TIGHTROPE NITINOL LOOP BROKE OFF IN THE K-WIRE WITHIN THE FIRST METACARPAL TUNNEL. THE LOOP WAS RETRIEVED AND REMOVED FROM INSIDE PATIENT, ANOTHER CMC MINI TIGHTROPE WAS OPENED. THE LOOP BROKE AGAIN IN THE TUNNEL, JUST LIKE THE PREVIOUS ONE; HOWEVER, THIS REMAIN PARTIALLY INTACT WITH THE WIRE AND DID NOT NEED TO BE REMOVED. THIS WAS DISCOVERED DURING A THUMB MCM SUSPENSIONPLASTY PROCEDURE ON (B)(6) 2022 BUT WAS COMPLETED AS AN LRTI PROCEDURE INSTEAD.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14546916 ↗
  • MalfunctionNov 22, 2021Break

    IT WAS REPORTED THAT DURING A HAND TRAPEZECTOMY SURGERY THE EYES OF THE 2 PINS OF THE DEVICE BROKE INSIDE THE PATIENT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12853169 ↗
  • InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT'S UNDERWENT A PROCEDURE WHERE A CMC TIGHTROPE, AR-8919DS, WAS IMPLANTED IN THEIR HAND. ABOUT 4-6 MONTHS POST-OP, THE PATIENT BEGAN TO EXPERIENCE DISTORTION OF THE ANATOMY AND THE SURGEON PLANS TO REVISE SURGERY. NO FURTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION OBTAINED 9/8/20: ARTHREX HAS BEEN ADVISED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2020 DURING WHICH TIME THE AR-8919DS WAS EXPLANTED.

    Patient problems: No Code Available

    MAUDE report 10562315 ↗
  • InjuryJun 27, 2019Patient-Device Incompatibility; Material Protrusion/Extrusion

    IT WAS REPORTED BY A PATIENT RELATIVE THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A TRAPEZIECTOMY DURING WHICH AN ARTHREX, AR-8919DS CMC MINI-TIGHTROPE, WAS IMPLANTED. PRIOR TO THE SURGERY SHE HAD EXPERIENCED INTERMITTENT PAIN BUT SINCE THE SURGERY THE PAIN HAS BEEN A CONSTANT CHRONIC PAIN. IN ADDITION, SINCE SURGERY THE PATIENT¿S USAGE OF HER HAND HAS DECREASED WITH ONLY ABOUT 50% MOBILITY WHICH IS MUCH LESS THAN PRIOR TO THE SURGERY. IN ADDITION, THE OUTLINE SHAPE OF THE IMPLANT DEVICE CAN BE SEEN PRESSING AGAINST THE SKIN. CALLER REQUESTED MATERIAL COMPOSITION OF THE DEVICE WHICH HAS BEEN PROVIDED TO THE PATIENT. CALLER AND PATIENT WERE ALSO SEEKING SURGEONS IN THEIR AREA THAT ARE EXPERIENCED WITH REMOVAL OF THE IMPLANT. ADDITIONAL INFORMATION OBTAINED 3/21/2019: PATIENT HAS HAD SEVERAL CONSULTATIONS AND IT IS REPORTED THE CONSENSUS IS THAT THE AR-8919DS, MINI-TIGHTROPE, NEEDS TO BE REMOVED. PATIENT CONTINUES TO HAVE QUITE A BIT OF PAIN WHERE THE BUTTONS ARE, ESPECIALLY THE ONE ON THE INDEX FINGER WHERE THE BUTTON IS VISIBLE JUST UNDER THE SKIN. IT HAS ALSO BEEN REPORTED THAT THE DOCTORS INDICATED THERE IS A POSSIBILITY THAT PATIENT MIGHT BE HAVING A REACTION TO ANY ONE OF THE DEV

    Patient problems: Limited Mobility Of The Implanted Joint; Pain

    MAUDE report 8739120 ↗
  • InjurySep 10, 2018Insufficient Device Problem Information

    IT WAS REPORTED BY A PATIENT THAT SHE HAD UNDERGONE A CMC MINI TIGHTROPE PROCEDURE ON (B)(6) 2018. SINCE THE PROCEDURE PATIENT HAS BEEN EXPERIENCING PAIN, INFLAMMATION, ADEMA AND SWELLING. PATIENT UNDERWENT METAL TESTING TO TRY AND DETERMINE THE CAUSE AND HAS LEARNED THAT SHE HAS AN ALLERGY TO NICKEL. PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY ON (B)(6) 2018 TO REMOVE THE ARTHREX CMC MINI TIGHTROPE. PATIENT REQUESTED THE MATERIAL COMPOSITION OF THE CMC MINI TIGHTROPE WHICH IS STAINLESS STEEL. THE COMPOSITION OF THE STAINLESS STEEL HAS BEEN PROVIDED TO PATIENT.

    Patient problems: Edema; Inflammation; Pain; Reaction; Swelling

    MAUDE report 7861029 ↗
  • InjuryDec 6, 2017Fracture

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE ON HER LEFT HAND FOR CMC JOINT ARTHRITIS IN (B)(6) 2016 WHERE A MINI TIGHTROPE WAS PLACED. IN (B)(6) 2017 THE SECOND METACARPAL FRACTURED ABOVE WHERE THE BUTTON WAS PLACED. THE FRACTURE WAS REPAIRED WITH PLATE/SCREWS AND THE TIGHTROPE REMOVED. THIS RESULTED IN A NON-UNION AND A THIRD SURGERY WAS DONE (B)(6) 2017 WITH A BONE GRAFT AND NEW PLATE/SCREWS. IT APPEARS TO BE HEALING BUT VERY SLOWLY. THE PATIENT FEELS AS IF THE TIGHTROPE PRODUCT FAILED. ADDITIONAL INFORMATION OBTAINED FROM PATIENT MEDICAL RECORDS (B)(6) 2017: OP REPORT (B)(6) 2016: PATIENT UNDERWENT A LEFT THUMB CARPOMETACARPAL JOINT TRAPEZIUM RESECTION AND SUSPENSION TIGHTROPE ARTHROPLASTY USING ARTHREX MINI TIGHTROPE SYSTEM. DURING THE PROCEDURE A 1.1 MM ARTHREX MINI TIGHTROPE CONSTRUCT WAS USED. OP REPORT (B)(6) 2017: PATIENT UNDERWENT A SECOND SURGERY FOR LEFT INDEX METACARPAL SHORT OBLIQUE EXTRAARTICULAR DISPLACED METACARPAL FRACTURE. REPORT NOTES THAT PATIENT HAD REPORTED THAT APPROXIMATELY 3 WEEKS PRIOR TO SECOND SURGERY SHE HAD STRUCK HER HAND ON THE BACK OF HER CAR. ALSO A FORCEFUL GRIPPING INCIDENT OCCURRED PRIOR TO SECOND SURGERY. WHEN THE PATIENT EXPERIENCE

    Patient problems: Failure of Implant; Impaired Healing; Pain

    MAUDE report 7086010 ↗

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