Arthrex® AR-1555BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867018853), received between Dec 27, 2017 and Sep 9, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionSep 9, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 9/4/2025: THE CASE WAS COMPLETED USING ANOTHER AR-1555BC BIOCOMPOSITE-TENODESIS SCREW. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT DID NOT SUFFER ANY ADVERSE EVENT ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004236 ↗
• 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 18960906 ↗
• MalfunctionAug 3, 2023Break; Break

  IT WAS REPORTED THAT THE SCREW BROKE OFF BEFORE INSERTION. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. NO FURTHER INFORMATION RECEIVED. UPDATE (B)(6)2023 NEN: THIS EVENT OCCURRED DURING SURGERY. THE BROKEN PIECES WERE RETRIEVED FROM 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 17453766 ↗
• MalfunctionMay 1, 2023Break; Break

  ON (B)(6)2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1555BC BIOCOMPOSITE-TENODESIS SCREW BROKE DURING INSERTION INTO THE FIBULA. THIS WAS DISCOVERED DURING AN ANTERIOR TALO-FIBULAR LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6)/2023. THE CASE WAS COMPLETED USING ANOTHER AR-1555BC BIOCOMPOSITE-TENODESIS SCREW FROM THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843686 ↗
• MalfunctionJun 6, 2022Break

  ON 5/20/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1555BC BIOCOMPOSITE-TENODESIS SCREW BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE RETRIEVED AND A SECOND BIOCOMPOSITE-TENODESIS SCREW WAS OPENED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN FHL TRANSFER ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603391 ↗
• MalfunctionMay 24, 2021Positioning Failure

  IT WAS REPORTED THAT DURING A ACL/PCL REPAIR, THE SCREW ROLLED AND COULD NOT BE USED. THE DEVICE WAS REMOVED AND THE CASE WAS COMPLETED BY USING A DIFFERENT DEVICE AS THE SURGEON SWITCH TO ANOTHER SURGICAL TECHNIQUE,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872108 ↗
• InjuryApr 18, 2018Break

  IT WAS REPORTED VIA FACILITY MEDWATCH REPORT (B)(4) THE DURING A LEFT SPLIT ANTERIOR TIBIAL TENDON TRANSFER PROCEDURE THE SURGEON WAS IMPLANTING THE AR-1555BC SCREW AND THE SCREW BROKE. THE DISTAL PORTION OF THE SCREW WAS RETAINED IN THE PATIENT'S BONE. THE PROXIMAL PORTION OF THE SCREW ABOVE THE BREAK WAS RETRIEVED AND SAVE BY THE FACILITY ORS QUALITY AS WELL AS THE DEVICE BOX WITH IMPLANT NUMBERS. PATIENT WAS A (B)(6) MALE. (B)(6) KG. NON-HISPANIC/LATINO FOLLOW-UP INVESTIGATION: DATE OF PROCEDURE WAS (B)(6) 2018. TO COMPLETE THE PROCEDURE A DIFFERENT SIZE OF THE SAME ARTHREX SCREW WAS USED AND PLACED IN ANOTHER LOCATION. FACILITY HAS THE DEVICE TO RETURN FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7439303 ↗
• InjuryDec 27, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A CYST FOLLOWING THE IMPLANTATION OF A BIO-ABSORBABLE SCREW AR-1390B 9 MM X 23 MM, 3 YEARS BEFORE. IMPLANTATION OF THE SCREW ON (B)(6) 2014, REMOVAL ON (B)(6) 2017. HISTOPATHOLOGICAL SAMPLING PERFORMED. FOLLOW-UP INVESTIGATION: THE SURGEON ALSO USED 2 FASTFIX. THE SURGERY WAS AN ACL RECONSTRUCTION. IMPLANTED DEVICES: AR-1555BC, LOT #:1189552; AR-1370B, LOT#: 1188967 AND AR-1390B, LOT #: 1189199.

  Patient problems: Cyst(s)

  MAUDE report 7147514 ↗