Arthrex® AR-2260BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888867204645), received between Aug 9, 2017 and Feb 13, 2026 — classified as 9 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (5 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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Material Twisted/Bent

  ON 27-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2260BC IMPLANT DELIVERY SYSTEM HAD BENT. THIS OCCURRED DURING A CASE WHILE INSERTING THE BUTTON PROPERLY, AND THE TIP OF THE INSERTER BENT, RENDERING THE DEVICE UNABLE TO HOLD THE BUTTON AND THEREFORE UNUSABLE. A NEW KIT HAD TO BE OPENED TO COMPLETE THE CASE. NO HARM WAS DONE TO THE PATIENT. ADDITIONAL INFORMATION WAS PROVIDED ON 02-FEB-2026 WHERE THE SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THIS EVENT OCCURRED DURING A DISTAL BICEPS REPAIR ON (B)(6) 2026. THE PATIENT HAD GOOD BONE QUALITY, THAT WAS PREPPED USING A SPADE-TIP PIN FROM THE KIT AND A REAMER CORRESPONDING TO TENDON SIZE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A NEW KIT WAS USED TO COMPLETE THE CASE. THIS EVENT RESULTED IN A FIVE-MINUTE DELAY WHICH DID NOT REQUIRE ADDITIONAL ANESTHESIA. ADDITIONAL INFORMATION WAS PROVIDED ON 04-FEB-2026 WHERE THE SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE DEVICE ONLY BENT. THERE WERE NO FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24337633 ↗
• InjuryJan 21, 2026Patient Device Interaction Problem

  ON 05-JAN-2026, IT WAS REPORTED BY THE PATIENT VIA EMAIL THAT THE PATIENT UNDERWENT PATELLAR TENDON RECONSTRUCTION IN (B)(6) 2025, DURING WHICH ARTHREX BICEPS BUTTON FIXATION DEVICES WERE UTILIZED BY THE OPERATING SURGEON. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SUBSTANTIAL POSTOPERATIVE COMPLICATIONS THAT SIGNIFICANTLY IMPACTED RECOVERY AND FUNCTIONAL OUTCOME. THE PATIENT NOTED THAT THESE COMPLICATIONS HAVE BEEN SEVERE AND PERSISTENT. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 16-JAN-2026: THE PATIENT UNDERWENT RIGHT PATELLAR TENDON RECONSTRUCTION ON (B)(6) 2024 FOLLOWING A PATELLAR TENDON RUPTURE ON (B)(6) 2024. THE PROCEDURE UTILIZED TWO AR-2260BC BIOCOMPOSITE DISTAL BICEPS IMPLANT SYSTEMS AND ONE AR-2323BCT-2 BIOCOMPOSITE SWIVELOCK SUTURE ANCHOR. APPROXIMATELY THREE WEEKS POSTOPERATIVELY, THE PATIENT REPORTED EARLY SYMPTOMS, NOTING THAT ¿SOMETHING FELT WRONG,¿ THOUGH THE OPERATING SURGEON INITIALLY ADVISED THIS WAS WITHIN NORMAL POSTOPERATIVE EXPECTATIONS. THE PATIENT SUBSEQUENTLY DEVELOPED SEVERE KNEE STIFFNESS, INABILITY TO BEND THE KNEE, AND EPISODES OF KNEE LOCKING. THESE SYMPTOMS REQUIRED A SECOND SURGERY, AFTER WHICH THE RANGE OF

  Patient problems: Arthrofibrosis; Swelling/ Edema

  MAUDE report 24129217 ↗
• MalfunctionJan 6, 2026Premature Activation

  IT WAS REPORTED THAT DURING A LEFT DISTAL BICEPS TENDON REPAIR SURGERY THE BUTTON ON THE DISTAL PORTION OF THE IMPLANT DEPLOYED BY ACCIDENT ON IMPLANTATION. AN X-RAY PICTURE WAS TAKEN ON THE PATIENT TO ATTEMPT TO LOCATE THE IMPLANT BUTTON BUT IT COULD NOT BE FOUND. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 23975161 ↗
• MalfunctionSep 9, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ON 08/19/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-2260BC BIOCOMPOSITE DISTAL BICEPS IMPLANT SYSTEMS EXPERIENCED AN ISSUE DURING A REPAIR PROCEDURE ON (B)(6) 2025. WHILE HOLDING TENSION TO INSERT THE SCREW INTO THE RADIAL TUBEROSITY DRILL TUNNEL, THE SUTURES SNAPPED INSIDE THE SCREW, PREVENTING PROPER TENSIONING. DESPITE THE ISSUE, THE CASE WAS COMPLETED, AND NO ADVERSE EFFECTS OR PATIENT HARM WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 08/22/2025: THE ISSUE OCCURRED INTRAOPERATIVELY, AND THE SNAPPED SUTURE WAS REMOVED FROM THE PATIENT. THE SUTURE FAILURE HAPPENED DURING THE INSERTION OF THE 7 MM X 10 MM BIOCOMPOSITE TENODESIS SCREW FROM THE KIT. THE CASE WAS COMPLETED USING AN AR-2260BC BIOCOMPOSITE DISTAL BICEPS IMPLANT SYSTEM. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 15¿20 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS EVENT OCCURRED DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008933 ↗
• MalfunctionSep 9, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  ON 08/19/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-2260BC BIOCOMPOSITE DISTAL BICEPS IMPLANT SYSTEMS EXPERIENCED AN ISSUE DURING A REPAIR PROCEDURE ON (B)(6) 2025. WHILE HOLDING TENSION TO INSERT THE SCREW INTO THE RADIAL TUBEROSITY DRILL TUNNEL, THE SUTURES SNAPPED INSIDE THE SCREW, PREVENTING PROPER TENSIONING. DESPITE THE ISSUE, THE CASE WAS COMPLETED, AND NO ADVERSE EFFECTS OR PATIENT HARM WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 08/22/2025: THE ISSUE OCCURRED INTRAOPERATIVELY, AND THE SNAPPED SUTURE WAS REMOVED FROM THE PATIENT. THE SUTURE FAILURE HAPPENED DURING THE INSERTION OF THE 7 MM X 10 MM BIOCOMPOSITE TENODESIS SCREW FROM THE KIT. THE CASE WAS COMPLETED USING AN AR-2260BC BIOCOMPOSITE DISTAL BICEPS IMPLANT SYSTEM. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 15¿20 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS EVENT OCCURRED DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23008682 ↗
• InjuryAug 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 08/25/2025: THE PATIENT REQUESTED CONFIRMATION WHETHER THE AR-2257 AC TIGHTROPE REPAIR KIT (LOT #09331, MANUFACTURED IN 2012) HAD STAINLESS STEEL COMPONENTS USED IN THAT SPECIFIC LOT IN THAT PERIOD (LOT #09331, MANUFACTURED IN 2012). THE PATIENT STATED THAT THE AR-2260BC BIOCOMPOSITE DISTAL BICEP IMPLANT SYSTEM HAD ALREADY BEEN SURGICALLY REMOVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22896852 ↗
• MalfunctionJan 2, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 12/05/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-2260BC BIOCOMPOSITE DISTAL BICEPS IMPLANT SYSTEM HAD THE BUTTON ON THE INSERTER USED TO FLIP THE BICEP BUTTON STUCK IN PLACE, SO IT COULD NOT FLIP. THIS WAS DISCOVERED DURING A DISTAL BICEP TENDON REPAIR PROCEDURE ON (B)(6) 2024, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12/10/2024: THE CASE WAS COMPLETED USING A DIFFERENT PRODUCT, THE AR-2280 IMPLANT SYSTEM, INSTEAD. THERE WAS NO CASE DELAY REPORTED. THE PATIENT HAS NOT EXPERIENCED ANY ISSUES AS THE PRODUCT WAS NOT USED DURING THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060593 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A TENSION SLIDE TECHNIQUE FOR DISTAL BICEPS TENDON THE SCREW BROKE DURING INSERTION. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. 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 20248114 ↗
• MalfunctionJul 17, 2024Crack; Crack

  ON 6/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE TENODESIS SCREW FROM AN AR-2260BC BIOCOMPOSITE DISTAL BICEPS REPAIR IMPLANT DELIVERY SYSTEM CRACKED DURING INSERTION. THE SCREW DID NOT BREAK INTO LOOSE PIECES AND WAS COMPLETELY REMOVED FROM INSIDE THE PATIENT. THE CASE WAS COMPLETED USING ANOTHER AR-2260BC BIOCOMPOSITE DISTAL BICEPS REPAIR IMPLANT. THIS WAS DISCOVERED DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19762775 ↗
• MalfunctionJul 17, 2024Positioning Failure; Positioning Failure

  ON 6/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2260BC IMPLANT DELIVERY SYSTEM HAD AN ISSUE DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2024. THE BIOCOMPOSITE SCREW IN THE KIT WOULD NOT SCREW INTO THE BONE; IT WOULD NOT SEAT. THE SCREW WAS REMOVED IN ONE PIECE FROM THE PATIENT, AND NOTHING BROKE INSIDE THE PATIENT. ANOTHER AR-2260BC IMPLANT DELIVERY SYSTEM WITH THE SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO HARM TO THE PATIENT. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE COMPLAINT DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19762465 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED DURING A DISTAL BICEPS REPAIR PROCEDURE, THE TENDON MEASURED AS A 7 AND THE SURGEON DRILLED PER TECHNIQUE TO AN 8. THE SURGEON WAS USING AR-2260BC (LOT: 11903191). UPON INSERTING THE SCREW, THE SCREW THREADS WERE CRUSHING AND THE SCREW WOULD NOT COME OFF THE DRIVER. A SECOND AR-2260BC FROM THE SAME LOT WAS OPENED FOR THE SCREW, AND THE SAME ISSUE OCCURRED. THE REP REPORTED THE PRODUCT DID NOT BREAK INTO DISCRETE PIECES AND REMAINED INTACT. THE CASE WAS COMPLETED BY NOT USING THE SCREW. THE SURGEON TOOK THE SUTURE AND PASSED IT BACK THROUGH THE TENDON AND TIED DOWN TO COMPLETE THE REPAIR. THE REP REPORTED THIS IS AN ACCEPTABLE METHOD OF FIXATION AND THE REPAIR WAS COMPLETED. BONE WAS VERY HARD.

  Patient problems: Insufficient Information

  MAUDE report 19487492 ↗
• MalfunctionJun 4, 2024Damaged Thread; Damaged Thread

  IT WAS REPORTED ON 12/09/2022 BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2260BC IMPLANT DELIVERY SYSTEM SCREW BEGAN TO STRIP AND WOULD NOT SEAT. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458913 ↗
• MalfunctionJun 4, 2024Positioning Failure; Positioning Failure

  ON 1/27/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2260BC IMPLANT DELIVERY SYSTEM HAD AN ISSUE. DURING A DISTAL REPAIR PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS OPENING THE KIT AND HE WAS PUTTING THE BIOCOMPOSITE SCREW INTO THE PATIENT, IT WOULD NOT SEAT IN THE BONE. THE SCREW WAS REMOVED IN ONE PIECE; NOTHING BROKE INSIDE THE PATIENT. ANOTHER AR-2260BC IMPLANT DELIVERY SYSTEM WITH AN UNKNOWN LOT NUMBER WAS OPENED. THIS TIME, THE SCREW SAT CORRECTLY IN THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458675 ↗
• MalfunctionMay 27, 2024Defective Device; Defective Device

  ON 10/5/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BUTTON FROM AN AR-2260BC BIOCOMPOSITE DISTAL BICEPS REPAIR IMPLANT DELIVERY SYSTEM, DID NOT HAVE A HOLE FOR THE INSERTER. ADDITIONAL INFORMATION RECEIVED ON 10/05/2022: THIS WAS DISCOVERED DURING A DISTAL BICEP REPAIR PROCEDURE AND COMPLETED USING ANOTHER AR-2260BC BIOCOMPOSITE DISTAL BICEPS REPAIR IMPLANT DELIVERY SYSTEM. NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400053 ↗
• MalfunctionMar 1, 2024Material Deformation; Material Deformation

  ON 02/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2260BC DISTAL BICEPS IMPLANT SCREW STRIPPED DURING INSERTION. PROCEDURE COMPLETED USING SCREW FROM ANOTHER KIT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816813 ↗
• MalfunctionDec 4, 2023Fitting Problem; Fitting Problem

  ON 11/2/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2260BC IMPLANT DELIVERY SYSTEM, BIOCOMPOSITE DISTAL BICEPS REPAIR, HAD A SCREW THAT DID NOT FIT IN THE INSERTER. THE CASE WAS COMPLETED BY SWAPPING FOR ANOTHER AR-2260BC FROM A DIFFERENT LOT WITH NO DELAY IN THE PROCEDURE. NO FRAGMENT BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A DISTAL BICEPS REPAIR ON 11/2/2023, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257763 ↗
• InjurySep 7, 2023Unexpected Therapeutic Results; Patient Device Interaction Problem; Unexpected Therapeutic Results; Patient Device Interaction Problem

  ON 8/9/2023, A PATIENT CALLED INQUIRING ABOUT THE COMPLICATIONS OF A DISTAL BICEP BUTTON TENSION SLIDE TECHNIQUE USING AN AR-2260BC BIOCOMPOSITE DISTAL BICEPS REPAIR IMPLANT SYSTEM. THE PATIENT HAD A PROCEDURE IN WHICH ARTHREX PRODUCTS WERE IMPLANTED BUT DID NOT KNOW THE PART NUMBERS. NO ALLEGATION OF PRODUCT DEFICIENCY OR ADVERSE EVENT WAS REPORTED WITHIN THIS INQUIRY. ADDITIONAL INFORMATION PROVIDED ON 8/14/2023: THE PATIENT REPORTED HAVING UNDERGONE SURGERY ON (B)(6) 2023 AND HAS BEEN UNABLE TO MOVE THE HAND OR LIFT THE FINGERS SINCE THE PROCEDURE. THE PATIENT WENT BACK TO THE SURGEON TO DISCUSS THE SYMPTOMS AND WAS ADVISED TO WAIT THREE MONTHS BEFORE PERFORMING FURTHER TESTING. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Discomfort

  MAUDE report 17700273 ↗
• InjuryJun 19, 2023Increased Sensitivity; Patient Device Interaction Problem; Increased Sensitivity; Patient Device Interaction Problem

  ON 5/24/2023, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT AN AR-2260BC BIOCOMPOSITE DISTAL BICEPS REPAIR IMPLANT DELIVERY SYSTEM WAS IMPLANTED DURING A PROCEDURE. THE PATIENT MAY BE EXPERIENCING HYPERSENSITIVITY TO THE IMPLANT. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 5/30/2023: THE PATIENT HAD A BICEP REPAIR PROCEDURE ON THE RIGHT SHOULDER AND IS EXPERIENCING HIVES AROUND THE AREA, ITCHING, BURNING, AND POKING. THE PATIENT WAS SENT TO AN ALLERGIST SPECIALIST; BLOOD WORK IS STILL PENDING. THE PATIENT HAS NOT HAD A REVISION SURGERY; ARTHREX PRODUCTS ARE STILL IMPLANTED.

  Patient problems: Burning Sensation; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 17152457 ↗
• InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 222, IT WAS REPORTED BY A PATIENT LEGAL REPRESENTATIVE VIA MAIL THAT ON (B)(6) 2020 A PATIENT SUFFERED A RIGHT DISTAL BICEP TENDON RUPTURE WHILE LIFTING A HAND TRUCK. ON (B)(6) 2021, PATIENT UNDERWENT AN OPEN PRIMARY REPAIR OF OF THE RIGHT DISTAL BICEP TENDON USING THE ARTHREX BICEP BUTTON AND TENSION SLIDE TECHNIQUE. A FEW DAYS LATER, ON (B)(6) 2021, THE REPAIR FAILED DURING THE COURSE OF LIFE ACTIVITIES AND PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. BOTH ORIGINAL AND REVISION SURGERY WERE PERFORMED AT THE SAME FACILITY WITH THE SAME SURGEON. THE ARTHREX BICEP BUTTON AND TENSION SLIDE TECHNIQUE PART NUMBER IS UNKNOWN AS WELL AS A LOT NUMBER. NO FURTHER INFORMATION HAS BEEN GIVEN AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 13995318 ↗
• InjuryJul 20, 2021Device Slipped

  IT WAS REPORTED DURING ELBOW PROCEDURE USING THE AR-2260BC, IMPL DELIVERY SYS,DISTAL BICEPS, BC. THE SURGEON INSERTED THE GUIDE PIN THROUGH THE CANNULATED AND GUIDE PIN PUSH THOUGH THE ELBOW WENT THROUGH THE PATIENTS SKIN ONTO TABLE AND THOUGH THE STERILE DRAPE. THE CASE WAS COMPLETED WITH NO ADDITIONAL ISSUES, THE SURGEON NOTICED THE DRILL GUIDE WAS BENT.

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

  MAUDE report 12196393 ↗
• MalfunctionMay 3, 2021Break

  IT WAS REPORTED DURING A DISTAL BICEPS REPAIR, WHILE ATTEMPTING TO INSERT THE BUTTON, THE TIP OF THE INSERTER BROKE OFF FROM THE KIT AR-2260BC. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. NO EXTRA INCISIONS WERE MADE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE AS PLANNED BY OPENING A NEW KIT AND USING A NEW INSERTER. THE BROKEN DEVICE IS NOT AVAILABLE FOR RETURN AND NO PICTURES WERE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11761645 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ALLERGIST'S OFFICE THAT A PATIENT HAS BEEN REFERRED TO THEM FOR AN ALLERGIC REACTION. PATIENT HAD A BICEPS TENDON REPAIR PROCEDURE ON (B)(6) 2016. DURING THE PROCEDURE THE PATIENT RECEIVED THE FOLLOWING IMPLANT: AR-2260BC, LOT 600093. THE REPORTER HAS REQUESTED MATERIAL COMPOSITION OF THE PATIENT'S IMPLANT. MATERIAL COMPOSITION HAS BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8861340 ↗
• InjurySep 5, 2018Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT HAD TO HAVE THREE DEVICES REMOVED FROM SHOULDER DUE TO INFECTION. ORIGINAL DATE OF SURGERY WAS (B)(6) 2018; IT WAS A ROTATOR CUFF REPAIR WITH BICEPS TENODESIS. THE CALLER HAD NO MORE INFORMATION ADDITIONAL INFORMATION OBTAINED (B)(6) 2018: DURING THE REVISION SURGERY ALL ORIGINAL IMPLANTS WERE REMOVED. NO DEVICES WERE IMPLANTED DURING THE SECOND SURGERY. CULTURES WERE TAKEN TO CONFIRM AN INFECTION. CULTURE RESULTS: CUTIBACTERIUN ACAS. PATIENT WAS PRESCRIBED ANTIBIOTICS FOR THE INFECTIONS. NO ADDITIONAL HOSPITAL STAY WAS REQUIRED.

  Patient problems: Bacterial Infection; No Code Available

  MAUDE report 7845540 ↗
• InjuryAug 9, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A DISTAL BICEPS REVISION SURGERY. THE PATIENT ORIGINALLY WAS NOTIFIED THAT THE IMPLANT WAS OUT OF RADIUS AND BACKED ITSELF OUT WHICH LED TO THE REASON FOR THE SECOND SURGERY. PER THE ARTHREX REPRESENTATIVE IN THE CASE, THE SURGEON TOOK X-RAYS AND OPENED UP THE SURGICAL SITE, BUT WAS UNABLE TO LOCATE THE SCREW TO BE REMOVED. THE SURGEON COULD NOT VISUALIZE THE SCREW OR FEEL IT. THE SCREW WAS NOT REMOVED FROM THE PATIENT AND THE SURGICAL SITE WAS CLOSED.

  Patient problems: No Code Available

  MAUDE report 6777669 ↗