Arthrex® AR-1540BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867018709), received between Aug 23, 2018 and Apr 6, 2026 — classified as 2 injuries, 6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Break

  ON 13-MAR-2026, A FACILITIES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-1540BC BIOCOMPOSITE TENODESIS SCREW FELL APART WHEN TAPPED AT THE INITIAL POINT OF INSERTION DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF A SCAPHOID FRACTURE. ALL FRAGMENTS WERE RETRIEVED, AND A NEW DEVICE WAS OPENED TO COMPLETE THE CASE WITH A MINIMAL TIME DELAY.

  Patient problems: Insufficient Information

  MAUDE report 24793544 ↗
• MalfunctionOct 12, 2023Fitting Problem; Fitting Problem

  ON 9/15/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1540BC BIOCOMPOSITE-TENODESIS SCREW 4 X 10 MM HAD AN ISSUE. DURING A CARPAL METACARPAL ARTHROPLASTY PROCEDURE ON (B)(6) 2023, WHEN THE SURGEON WAS TRYING TO IMPLANT THE SCREW, IT WAS NOT AS TIGHT OF A FIT AS PREFERRED, AND THE DEVICE WOULD NOT SEAT CORRECTLY. THE SCREW WAS REMOVED IN ONE PIECE, NOTHING BROKE INSIDE THE PATIENT, AND A MINI TIGHTROPE IMPLANT SYSTEM WITH AN UNKNOWN PART AND LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO CASE DELAY AND NO HARM TO THE PATIENT. THE SCREW WAS DISCARDED BY THE FACILITY, NO PICTURES WERE TAKEN. THIS OCCURRED DURING USE WITH NO PATIENT HARM.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920628 ↗
• MalfunctionDec 7, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA EMAIL THAT AR-1540BC BIO-COMPOSITE-TENODESIS¿ SCREW BROKE DURING INSERTION. THE SURGEON REMOVED ALL FRAGMENTS AND COMPLETED THE CASE WITH A NEW ONE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931157 ↗
• MalfunctionJun 27, 2022Break

  ON 6/13/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1540BC BIO-COMPOSITE-TENODESIS SCREW BROKE DURING INSERTION. SURGEON WAS ABLE TO RETRIEVE ALL BROKEN FRAGMENTS. THIS WAS DISCOVERED DURING AN ANKLE SIDE INSTABILITY PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14829167 ↗
• MalfunctionApr 20, 2021Break

  IT WAS REPORTED THAT DURING A BIO TENODESIS, THE AR-1540BC, BROKE WHEN THE SURGEON WAS PLACING IT INTO THE PATIENT'S BONE. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-1540BC.

  Patient problems: Insufficient Information

  MAUDE report 11692634 ↗
• MalfunctionFeb 22, 2021Break

  IT WAS REPORTED THAT DURING A DEX PROCEDURE, WHEN THE SURGEON WAS USING THE AR-1540BC, THE ANCHOR BROKEN. SINCE THE ANCHOR BROKE, THE SURGEON DECIDED TO REMOVE ALL FRAGMENTS AND USE A TENODESIS SCREW INSTEAD WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358007 ↗
• InjuryDec 13, 2018Appropriate Device Problem Term/Code Not Available

  DURING SOCIAL SAFEGUARD CYBER REVIEW A CONVERSATION WAS DISCOVERED WHICH MENTIONED A HAMMERTOE REVISION PROCEDURE. UPON FURTHER INVESTIGATION IT WAS DISCOVERED THAT A PATIENT HAD UNDERGONE A REVISION SURGERY ON (B)(6) 2018. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED AN AR-1540BC, BIO-COMPOSITE TENODESIS SCREW. THE EXPLANTED SCREW WAS FULLY INTACT, WAS REMOVED AND DISCARDED AT TIME OF PROCEDURE. ONCE THE SCREW WAS REMOVED THE SURGEON FILLED THE VOID WITH 1 CC OF ALLOSYNC PUTTY AND THEN PLACED STAPLES. THE REASON FOR PERFORMING THE REVISION AND REMOVING THE SCREW IS BECAUSE THE SURGEON EXPRESSED CONCERN ABOUT POOR BONE QUALITY. SURGEON PROVIDED NO FURTHER INFORMATION TO THE SALES REP WITH REGARD TO THE REVISION. THE ORIGINAL PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON IN A DIFFERENT CITY AND FURTHER DETAILS FROM THAT PROCEDURE ARE NOT AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8160323 ↗
• InjuryAug 23, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A CARPAL-META CARPAL FASCIA ARTHROPLASTY WITH LIGAMENT RECONSTRUCTION PROCEDURE WHERE A BIOCOMPOSITE-TENODESIS¿ SCREW 4 X 10 MM, AR-1540BC, WAS IMPLANTED. ABOUT 5 WEEKS POST-OP, THE PATIENT BEGAN TO EXPERIENCE REDNESS AND SWELLING AT THE INCISION SITE. THE PATIENT WAS HOSPITALIZED AND TREATED WITH IV ANTIBIOTICS. THE SUTURE USED IN THE SURGERY WAS FROM ETHICON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Erythema; Swelling

  MAUDE report 7809849 ↗