Arthrex® AR-1547BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867018778), received between Jul 13, 2018 and Feb 24, 2026 — classified as 5 injuries, 12 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. 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Break

  ON 09-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1547BC BIOCOMPOSITE-TENODESIS SCREW 4.75 X 15 MM BROKE UPON INSERTION AND BEGAN TO BACK OUT. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED USING TWO AR-4020C-07 BIOCOMPOSITE FASTTHREAD FASTTHREAD BIOCOMPOSITE INTERFERENCE SCREW 7 X 20 MM (BATCHES 15468502 AND 15426402). THE ISSUE OCCURRED DURING AN ACL RECONSTRUCTION ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 16-FEB-2026: THERE WAS NO CASE DELAY. A PHOTO WAS PROVIDED SHOWING THE DETACHED SCREW FRAGMENTS; HOWEVER, IT HAS NOT BEEN CONFIRMED WHETHER ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429742 ↗
• MalfunctionOct 24, 2024Break; Break

  IT WAS REPORTED THAT DURING AN AUTOCART SURGERY THE SCREW BROKE INSIDE THE TUNNEL. ALL PARTS WERE RETRIEVED. 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 20523905 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT DURING A SMALL SURGERY THE SCREW BROKE IN THE TUNNEL ON THE EMBANKMENT. ALL FRAGMENTS 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 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 20260343 ↗
• InjuryJul 10, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION: THE PART NUMBER FOR THE SCREW USED TO COMPLETE THE CASE SUCCESSFULLY WAS AN AR-8922 12MM SUTURE BUTTON. MINIMAL ADDITIONAL TIME WAS ADDED TO THE CASE TO REPASS THE TENDON INTO THE BONE SOCKET.

  Patient problems: Insufficient Information

  MAUDE report 19709222 ↗
• MalfunctionJun 17, 2024Break; Break

  IT WAS REPORTED THAT DURING TENDON TRANSFER FOOT SURGERY WHEN INSERTING THE SCREW INTO THE BONE IT CRACKED. NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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 SWIT 17-FEB-2021: THE SCREW DID NOT BREAK OFF (IT DIDN´T BREAK IN SEVERAL PARTS) AND NOTHING IS REMAINING IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547141 ↗
• MalfunctionMar 22, 2024Break; Break

  ON 03/11/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-1547BC SCREW AND AN AR-1555BC SCREW BROKE. THIS OCCURRED DURING A TENDON TRANSFER/TENODESIS ON (B)(6) 2024 WHEN BOTH SCREWS BROKE WHILE TRYING TO INSERT AND PERFORM THE TENODESIS. A SWIVELOCK WAS USED TO COMPLETE THE CASE. ADDITIONAL INFORMATION RECEIVED ON 3/13/2024: ALL BROKEN FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18960827 ↗
• MalfunctionOct 9, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 9/26/2023: THE CASE WAS DELAYED SIXTY MINUTES, AND ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE SURGEON WAS UNABLE TO REMOVE ALL THE BROKEN FRAGMENTS THAT WERE INSIDE THE PATIENT.

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 17897383 ↗
• MalfunctionAug 2, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW BROKE DURING INSERTION. 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 SWIT (B)(6) 2023: THE DEVICE BROKE OUTSIDE THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442405 ↗
• InjuryOct 24, 2022Break; Nonstandard Device; Physical Resistance/Sticking

  ON 10/6/2022, IT WAS REPORTED BY A PATIENT VIA PHONE THAT SHE HAD A REACTION TO QTY. 2 OF AN AR-1547BC TENO SCRW, BIO-COMP AFTER A REVISION SURGERY ON (B)(6) 2015. IN THE SPRING OF 2009, SHE BROKE THE FRONT LEFT CLAVICLE, IT WAS SHATTERED UPON IMPACT IN A CAR ACCIDENT, AND DURING SURGERY ONE OR TWO METAL PLATES WERE IMPLANTED. SHE WAS NOT SURE IF THE FIRST SET OF SCREWS THAT WERE USED TO AFFIX THE METAL PLATES WERE ARTHREX PRODUCTS. ON (B)(6) 2015, A REVISION SURGERY TOOK PLACE, BECAUSE THE METAL PLATE WAS STICKING OUT FROM THE BACK OF THE CLAVICLE, IT COULD BE FELT UNDER THE SKIN AND THE SKIN WAS DEFORMED. AN ARTHROSCOPIC SURGERY TOOK PLACE, THE SURGEON USED A TENDON GRAFT, RE-ATTACHED THE PECTORAL MUSCLE, AND USED QTY. 2 OF AN AR-1547BC TENO SCRW, BIO-COMP. ABOUT A YEAR AFTER THE REVISION SURGERY, HER CLAVICLE STARTED SWELLING, FLUID BUILT UP ON THE BASE OF THE NECK, SHE HAD WATER SWELLING UNDER THE BREAST AND THE ARM, AND SHE ALSO HAS AN ALLERGY TO PLASTIC. THE PATIENT ALSO HAS BREAST IMPLANTS. SHE WENT TO PHYSICAL THERAPY. WHEN USING HER LEFT ARM, OR DOING PHYSICAL ACTIVITY, THE LEFT SIDE OF THE CLAVICLE SWELLS UPS, AND IT TRAVELS TO THE RIGHT SIGHT (GOLF BALL SIZE). THE DOCTOR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 15657418 ↗
• MalfunctionOct 3, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1547BC SCREW BROKE UPON INSERTION. THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT SPACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15534098 ↗
• InjuryMay 23, 2022Patient-Device Incompatibility

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT PATIENT HAD AN ALLERGIC REACTION POST OPERATIVE TO AR-1547BC BIO-COMPOSITE-TENODESIS SCREW. NO FURTHER INFORMATION HAS BEEN GIVEN AS OF TODAY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 14469938 ↗
• MalfunctionOct 5, 2021Fracture; Material Fragmentation

  IT WAS REPORTED THAT DURING FOOT ARTHROSCOPY SURGERY THE SURGERY INCLUDED A CALCANEAL OSTEOTOMY AND TENDON TRANSFER (FOR VALGUS FLATFOOT). THE TENDON TRANSFER (FDL), PASSED THROUGH A TUNNEL DRILLED IN THE NAVICULAR BONE, IT WAS FIXE BY A 4.75MM DIAMETER INTERFERENCE SCREW. DURING THE SCREWED ONTO THE GUIDE WIRE, THE SCREW FRACTURED AND FRAGMENTED. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. SURGEON SECURED THE FIXATION WITH A SECOND SCREW OF IDENTICAL MODEL. THERE WAS NO HARM 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. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576384 ↗
• MalfunctionSep 21, 2021Break

  IT WAS REPORTED THAT DURING TALUS SURGERY WHEN THE SCREW WAS PLACED ON A DENSE BONE AT THE TALUS, IT BEGAN TO CRUMBLE. IT WAS NECESSARY TO USE ANOTHER SCREW WITH A LAGER DIAMETER. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE AR-1555BC. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12506039 ↗
• MalfunctionMay 3, 2021Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING A FLEXOR DIGITORUM LONGUS TENDON TRANSFER SURGERY. AFTER INSERTING THE SCREW THE DRIVER WAS REMOVED AND THE SCREW JUST CAME OUT IN BITS, ALTHOUGH THE BONE WAS ASSESSED AS SOFT AND NOTHING IMPACTED ON THE SCREW DURING INSERTION. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. ACCORDING TO THE SURGEON THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE WITH THE PART NUMBER AR-1555BC. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 11761347 ↗
• MalfunctionMar 12, 2021Material Fragmentation

  IT WAS REPORTED THAT DURING ARTHROSCOPY WHEN THE SCREW WAS TIGHTENED THE SCREW CRUMBLED. ALL PIECES WERE RETRIEVED FROM PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475437 ↗
• InjuryJul 15, 2020Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ANKLE SURGERY WHILE INSERTING THE SCREW IT BROKE INTO SEVERAL SMALL FRAGMENTS. THE SURGEON NEEDED ADDITIONAL 30 MINUETS TO RETRIEVE ALL PARTS OUT OF THE PATIENT. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS 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 23-JUN-2020: IT WAS FURTHER REPORTED THAT AN ADDITIONAL ANESTHESIA WAS NEEDED.

  Patient problems: No Code Available

  MAUDE report 10279362 ↗
• InjuryJul 13, 2018Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A RIGHT ANKLE LATERAL LIGAMENT ALLOGRAFT RECONSTRUCTION AND PROXIMAL TENDON PROCEDURE ON (B)(6) 2017 DURING WHICH THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: BIOTENODESIS SCREW, AR-1547BC, LOT 10044519; 6.25 X 15 MM SCREW, AR-1562BC, LOT 10040350; AND 5.5 X 15MM SCREW, AR-1555BC, LOT 10050790. ALSO IMPLANTED WAS ANOTHER MANUFACTURER'S ALLOGRAFT TISSUE, TENDON SEMITENDINOSUS PRODUCT. AFTER SURGERY AND SINCE HEALING THE PATIENT EXPERIENCED THE FOLLOWING ISSUES: PAIN WHERE THE NEW TENDON WAS SUPPOSED TO BE, A LUMP THAT STUCK OUT OF THE SKIN, INFLAMMATION, WEAKNESS, PAIN. PATIENT WAS TREATED WITH PHYSICAL THERAPY, BRACING, LIMITED DRIVING AND LIMITED PHYSICAL ACTIVITY. ON (B)(6) 2017 PATIENT UNDERWENT A RIGHT PERONEAL TENDOSYNOVITIS AND PROMINENT HARDWARE REMOVAL PROCEDURE, BY THE SAME SURGEON AT THE SAME FACILITY, DUE TO FAILING CONSERVATIVE TREATMENT FOR PATIENT'S PERSISTENT POSTEROLATERAL ANKLE PAIN AND A PALPABLE MASS. SURGEON DISLOCATED THE PERONEAL TENDONS FROM THE RETROFIBULAR GROOVE AND THEY WERE FREE OF ANY NEW TEARS. THERE WAS EXTENSIVE TENOSYNOVITIS WITH THICKENED TENOSYNOVIUM, WHICH WAS SHARPLY DEBRIDED. THERE WAS A PROMIN

  Patient problems: Inflammation; Irritation; Pain; Synovitis; Weakness

  MAUDE report 7684824 ↗