Arthrex® AR-2260Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888867026476), received between Apr 21, 2017 and Jul 30, 2026 — classified as 9 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Material Twisted/Bent

  On 13-Jul-2026, a sales representative reported via email that an AR-2260 Distal Biceps Repair Implant System experienced an issue during a procedure on (b)(6) 2026. The tip of the blue-handle inserter reportedly bent and could no longer retract, preventing release and deployment of the button. All components were retrieved. The case was completed using two AR-1915FT Corkscrew FT with needle devices. No patient harm was reported.Additional information was received on 16-Jul-2026:The procedure being performed was a distal biceps repair. The inserter tip became bent during insertion, preventing successful implantation of the button. It was reported that no device components remained in the patient. The procedure was delayed by approximately 5 minutes, and an additional 5 minutes of anesthesia was administered. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50081598 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SURGERY THE WIRE HAD A BEND/CURVE IN THE MIDDLE. THIS MEANT THAT IT WAS NOT POSSIBLE TO DRILL THROUGH WITH THE LARGE, CANNULATED DRILL BIT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629929 ↗
• MalfunctionMay 23, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A DISTAL BICEPS SURGERY THE TIGHTROPE BUTTON DID NOT HOLD ONTO THE INSERTER. IT FELL OFF THE INSERTER WHILE INSERTING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079338 ↗
• MalfunctionFeb 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DISTAL BICEPS TENDON REFIXATION THE SUTURE HAS TORN WHILE KNOTTING / WORKING WITH IT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 DW 28-JAN-2025 FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN SUTURES WERE REMOVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399618 ↗
• MalfunctionFeb 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A DISTAL BICEPS TENDON REFIXATION THE SUTURE HAS TORN WHILE KNOTTING / WORKING WITH IT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 (B)(6)2025. FURTHER INFORMATION WAS PROVIDED THAT THE BROKEN SUTURES WERE REMOVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21347096 ↗
• MalfunctionOct 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 10/18/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM FIRST CONSTRUCT WAS RELEASED IN THE PAVILION; THE SUTURES WERE RELEASED FROM THE BUTTON. THE TENDON WAS RELEASED FROM THE TUNNEL. THE SUTURES DETACH FROM THE BUTTON, RETURNING THE BICEPS THROUGH THE TUNNEL. THE BUTTON COULD NOT BE RECOVERED AND REMAINED INSIDE THE PATIENT. THE CASE WAS COMPLETED USING A NEW AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM. THIS WAS DISCOVERED DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 20532463 ↗
• MalfunctionOct 24, 2024Break; Break

  ON 10/3/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM NEEDLE BROKE OFF OF THE SUTURE AND THE BUTTON INSERTER WOULD NOT FUNCTION PROPERLY. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/18/2024: THIS WAS DISCOVERED ON THE BACK TABLE DURING A DISTAL BICEP REPAIR PROCEDURE. THE CASE WAS COMPLETED USING PEEL-PACKED INSTRUMENTS, WHICH DELAYED THE PROCEDURE FOR ABOUT FIVE SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522605 ↗
• MalfunctionJun 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 05/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2260 IMPLANT DELIVERY SYSTEM BUTTON WOULD NOT FIT IN THE BUTTON INSERTER. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505427 ↗
• MalfunctionMay 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM HAD SUTURES THAT WOULD NOT SLIDE INTO THE BUTTON. THE REP BELIEVES THEY MAY HAVE BEEN CAUGHT ON THE BUTTON. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT OR DELAY IN THE CASE AND NO PHOTOS TAKEN. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-2260 KIT AND USED ITS BUTTON. THIS WAS DISCOVERED DURING A DISTAL BICEP REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19395520 ↗
• MalfunctionMay 6, 2024Failure to Advance; Failure to Advance

  ON 04/11/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-2260 IMPLANT SYSTEM DRILL PIN HAD A RIDGE ON THE MIDDLE SECTION OF THE PIN AND THE DRILL BIT COULD NOT ADVANCE PAST THE RIDGE. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE WAS COMPLETED USING A NEW PIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19250497 ↗
• MalfunctionApr 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 2/15/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-2260 DISTAL BICEPS DELIVERY SYSTEM HAD ISSUES WITHY THE REAMER. DURING A DISTAL BICEPS REPAIR THE REAMER KEPT GETTING STUCK ABOUT HALF WAY DOWN ON THE GUIDE PIN. DIFFERENT REAMERS WERE TRIED BUT THEY ALL KEPT GETTING STUCK ON THE PIN. THE DOCTOR REAMED FREE HAND TO FINISH THE CASE SUCCESSFULLY WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173308 ↗
• MalfunctionApr 10, 2024Failure to Advance; Failure to Advance

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 7.5MM REAMER WAS PLACED OVER THE PIN OF AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM, AND IT WOULD NOT ADVANCE TO REAM. ANOTHER KIT WAS OPENED AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. ONCE WAS FINISHED, UPON EVALUATION, IT WAS DISCOVERED THAT THE PIN HAD A NICHE IN THE METAL, WHICH PREVENTED THE REAMER FROM ADVANCING DOWN. THIS WAS DISCOVERED DURING A DISTAL BICEP REPAIR PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 19078374 ↗
• MalfunctionApr 8, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED ON 04/27/2022 BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AN AR-2260 DISTAL BICEP IMPLANT WOULD NOT SEAT. THIS OCCURRED DURING A CASE WITH NO PATIENT HARM. PER FACILITY: "THE IMPLANT SCREW WAS NEVER FIXED TO THE BICEPS; ALL ATTEMPTS WERE MADE BUT IT WAS NOT POSSIBLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067657 ↗
• InjuryDec 27, 2023Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  ON 11/27/2023 IT WAS REPORTED BY A PATIENT'S LEGAL REPRESENTATIVE VIA EMAIL THAT, BASED ON THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT DISTAL BICEPS REPAIR. THE OPERATIVE REPORT NOTES THAT DURING THE PROCEDURE AN ARTHREX ENDO BUTTON SYSTEM WAS USED TO REPAIR THE BICEPS. THE PART/LOT WAS NOT PROVIDED. FOLLOWING THE PROCEDURE, THE MEDICAL RECORDS DATED MAY 26, 2016, INDICATE THAT ¿EARLIER THIS WEEK, HE WAS FALLING AND GRABBED SOMETHING WITH HIS OUTSTRETCHED RIGHT ARM AND FELT A BIT OF A TEARING SENSATION IN HIS RIGHT FOREARM.¿ THE PATIENT CONTINUED TO HAVE PAIN AND WEAKNESS IN THE RIGHT ARM AND ON (B)(6) 2017, A REVISION SURGERY WAS PERFORMED USING ARTHREX¿S AR-2260 DISTAL BICEPS IMPLANT SYSTEM (LOT 10022755). THE REVISION OPERATIVE REPORT INDICATES A RIGHT DISTAL BICEPS RE-RUPTURE. THIS CASE IS RELATED TO CASE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 18397804 ↗
• MalfunctionDec 10, 2023Fitting Problem; Fitting Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM BUTTON INSERTER WAS TOO THICK. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A DISTAL BICEP REPAIR PROCEDURE ON (B)(3) 2023. THE CASE WAS COMPLETED BY OPENING ANOTHER R-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM.

  Patient problems: Insufficient Information

  MAUDE report 18298468 ↗
• InjuryNov 9, 2023Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  ON 10/17/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06060226 AND CONFIRMED VIA PHONE THAT THE GUIDE PIN FROM AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM WAS PUSHED DOWN BY THE REAMER DURING DRILLING, AND IT PUNCTURED A HOLE THROUGH THE PATIENT AND THE DRAPES, FROM THE INSIDE OUT. THIS WAS DISCOVERED DURING A DISTAL BICEP RECONSTRUCTION PROCEDURE ON 10/16/2023. THE CASE WAS COMPLETED BY USING ANOTHER GUIDE PIN. THE PUNCTURE WAS DRESSED IN STERILE STRIPS AND PADS AND IS BEING MONITORED FOR INFECTIONS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18101573 ↗
• InjuryOct 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  AN INITIAL INQUIRY WAS RECEIVED THAT INDICATED A PATIENT HAS BEEN EXPERIENCING ISSUES SINCE RECEIVING AN ARTHREX IMPLANT. ON (B)(6) 2019 THE SURGEON CONFIRMED THAT HE WAS NOT REPORTING AN ADVERSE EVENT. HE STATED THAT HE HAS A VERY DIFFICULT PATIENT WHO HAD A DISTAL BICEP REPAIR WHICH HAS HEALED. THE PATIENT HAS PAIN AND CRAZY SYMPTOMS (TYPE OF SYMPTOMS WERE REQUESTED BUT SURGEON DID NOT ELABORATE). THERE IS NOTHING ON HIS EXAM OR MRI TO INDICATE THERE IS A PROBLEM WITH THE IMPLANT. A SECOND OPINION PHYSICIAN HAD POSED THE QUESTION OF PEEK ALLERGY/SENSITIVITY. THE SURGEON HAD REACHED OUT TO ARTHREX IN AN ATTEMPT TO OBTAIN A FLAT SAMPLE TO PUT ON THE PATIENT¿S SKIN FOR TESTING. AT THIS TIME SPECIFIC PART NUMBERS HAD NOT BEEN PROVIDED. ARTHREX REQUESTED ADDITIONAL INFORMATION. ON (B)(6) 2019 THE SURGEON RESPONDED PROVIDING THE SPECIFIC PART NUMBER, AR-2260 (LOT 10022755) DISTAL BICEP KIT WITH PEEK BIOTENODESIS SCREW. DATE OF PATIENT SURGERY WAS (B)(6) 2017. SURGEON STATES PATIENT HAS ALWAYS HAD PAIN WITH NO DISCERNIBLE CHANGE FROM PRE-OP TO POST-OP. PATIENT HAS UNDERGONE EXTENSIVE DIAGNOSTIC EVALUATION INCLUDING MRI. PATIENT HAS NUMEROUS ALLERGIES SO MEDICAL TREATMENT IS DIFFICULT. P

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18040589 ↗
• MalfunctionOct 10, 2022Degraded; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2260 DISTAL BICEPS IMPLANT SYSTEM IMPLANTS THREADS STRIPPED OUT AND BACKED OUT OF THE BONE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: Failure of Implant

  MAUDE report 15570830 ↗
• MalfunctionAug 18, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM SCREW CRACKED OFF WHEN THE SURGEON WAS PLACING IT. THIS WAS DISCOVERED DURING AN DISTAL BICEPS PROCEDURE. THE BROKE FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW AR-2260 WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15249405 ↗
• MalfunctionJun 13, 2022Break; Difficult to Remove

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA MEDWATCH EMAIL THAT A DRILL BIT FROM AN AR-2260 DISTAL BICEPS REPAIR IMPLANT SYSTEM BROKE OFF IN THE PATIENT'S RIGHT SHOULDER. SURGEON DID NOT RETRIEVE THE BROKEN FRAGMENT DUE TO CAUSING MORE DAMAGE THAN LEAVING IT IN. THIS WAS DISCOVERED DURING A DISTAL BICEPS REPAIR ON (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 14676460 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD A DISTAL BICEP REPAIR DONE IN LATE (B)(6) 2020 AND HAS HAD A BODY RASH SINCE THAT TIME. ADDITIONAL INFORMATION OBTAINED 12/18/2020: THE PATIENT'S IMPLANT SURGERY WAS(B)(6) 2020. HIS SYMPTOMS FIRST APPEARED (B)(6) 2020. SYMPTOMS HAS BEEN A RASH COVERING HIS BODY. TO DATE THE SYMPTOMS HAVE BEEN TREATED WITH CREAMS, ANTIHISTAMINES, AND PHOTOTHERAPY. NO CULTURES HAVE BEEN TAKEN TO DATE. PATIENT ALSO STATES THAT AS OF THIS DATE HIS SURGEON, ER DOCTOR, ALLERGIST AND ONE DERMATOLOGIST ALL AGREE THAT THE RASH HAS NOTHING TO DO WITH HIS IMPLANT. HIS LAST DERMATOLOGIST ALSO THINKS THAT IT IS NOT BEING CAUSED BY THE IMPLANT. THAT DERMATOLOGIST SUGGESTED RESEARCHING THE COMPONENTS TO SEE IF PATIENT IS POSSIBLY ALLERGIC TO ANYTHING IN THE IMPLANT. THE DERMATOLOGIST IS CONVINCED ALSO THAT WHATEVER THE PATIENT IS EXPERIENCING HAS NOTHING TO DO WITH THE IMPLANTS. MATERIAL COMPOSITION HAS BEEN PROVIDED TO THE PATIENT.

  Patient problems: Rash

  MAUDE report 11117374 ↗
• InjuryJun 27, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN RIGHT DISTAL BICEPS TENDON REPAIR PROCEDURE ON (B)(6) 2018 WHERE AN ARTHREX DISTAL BICEPS REPAIR SYSTEM, AR-2260, WAS USED. ON (B)(6) 2018, THE PATIENT REPORTED VIA PHONE CALL TO HIS PHYSICIAN'S OFFICE THAT HE NOTICED "THE INCISION LOOKING RED AND SOME YELLOW DRAINAGE COMING FROM THE INCISION". THE PATIENT WAS THEN PRESCRIBED A COURSE OF AUGMENTIN BY PHYSICIAN. AT THIS POINT IN TIME, THE SURGEON WILL NOT PERFORM A SECOND SURGERY.

  Patient problems: Post Operative Wound Infection; Purulent Discharge

  MAUDE report 7642839 ↗
• InjuryApr 18, 2018Patient-Device Incompatibility

  IT WAS REPORTED VIA MAUDE LETTER (MW5075494) AND MAUDE REVIEW THAT A PATIENT UNDERWENT A RIGHT SHOULDER ARTHROSCOPY WITH A SUBPECTORALIS BICEPS TENODESIS FOR TREATMENT OF A SUPERIOR LABRAL SLAP TEAR ON (B)(6) 2017. A COMBINATION OF TITANIUM METAL BUTTON, FIBERWIRE SUTURE AND A PEEK INTERFERENCE SCREW FROM THE ARTHREX DISTAL BICEPS REPAIR KIT (AR-2260) WERE USED FOR BONY ATTACHMENT OF THE LONG HEAD BICEPS TENDON TO THE PROXIMAL HUMERUS. FOLLOWING SURGERY THE PATIENT INITIALLY REPORTED IMPROVEMENT IN PAIN WITH OVERHEAD MOTION BUT BEGAN TO NOTE TENDERNESS AT THE SITE OF THE TENODESIS ALONG WITH LATER REDNESS, SWELLING, WELTS AND ITCHING OF THE RIGHT UPPER EXTREMITY, CHEST AND BACK WHICH WORSENED WITH TIME AND REQUIRED USE OF ALLERGY/ANTIHISTAMINE MEDICATIONS IN ORDER TO PARTIALLY RELIEVE THE SYMPTOMS. THE PATIENT WAS EVENTUALLY REFERRED TO AN ALLERGY SPECIALIST WHO CONFIRMED A STRONG ALLERGY TO THE PEEK MATERIAL WITH PATCH TESTING AND RECOMMENDED REMOVAL OF THE IMPLANT WHICH WAS PERFORMED ON (B)(6) 2018. ALONG WITH REVISION OF THE TENODESIS USING A NEW TITANIUM BUTTON. THE MAUDE LETTER (MW5075494) LISTED LOT 1015727 WHICH IS NOT A VALID NOT NUMBER FOR AR-2260. CONFIRMATION HAS BEEN RE

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Itching Sensation; Swelling

  MAUDE report 7439296 ↗
• InjuryDec 21, 2017Break; Detachment Of Device Component; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A DISTAL BICEPS REPAIR PROCEDURE, AFTER THE SURGEON INSERTED THE INSERTER THROUGH THE CORTICES, INSTEAD IF PUSHING THE BUTTON, HE YANKED THE DEVICE AND THE TIP OF THE INSERTER-BROKE OFF AND WAS UNABLE TO BE RETRIEVED. A POST-OP X-RAY WAS TAKEN AND THE BROKEN TIP OF THE DEVICE WAS VISIBLE. THE BUTTON WAS FULLY SEATED AND THE CASE WAS COMPLETED AS EXPECTED. PATIENT IS A MALE, (B)(6).

  Patient problems: Foreign Body In Patient

  MAUDE report 7137336 ↗
• InjuryAug 28, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PATIENT HAD RIGHT SHOULDER BICORTICAL PROXIMAL SUBPECTORAL TENODESIS SURGERY ON (B)(6) 2016. AFTER SURGERY EVERYTHING WAS ON SCHEDULE WITH PHYSICAL THERAPY AND HEALING. IN (B)(6) 2017 THE PATIENT STARTED TO EXPERIENCE SHARP PAIN IN HIS SHOULDER. HE WENT TO THE DOCTOR AND HAD AN X-RAY PERFORMED. THE TITANIUM BUTTON HAD DETACHED FROM THE BONE AND WAS IN THE SHOULDER JOINT. REVISION SURGERY DONE ON (B)(6) 2017. FOLLOW UP INVESTIGATION: IN (B)(6) 2017 PATIENT WENT TO THE DOCTOR DUE TO SHARP PAIN IN THE SHOULDER. A MRI WAS PERFORMED AND A METALLIC FOREIGN BODY WAS VISIBLE NEAR THE BASE OF THE CORACOID PROCESS. A X-RAY WAS ALSO PERFORMED TO CONFIRM THE FINDINGS OF THE MRI.

  Patient problems: Failure of Implant; Pain

  MAUDE report 6823447 ↗