Arthrex® AR-1580BCRecalls & reported problems
Arthrex, Inc. · TENO SCRW,BIO-COMP · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867019034), received between Aug 16, 2017 and Dec 15, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hypersensitivity/Allergic reaction1
- Inflammation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2023Break; Break
IT WAS REPORTED THAT DURING AN ANKLE JOINT ARTHRODESIS SURGERY THE IMPLANT BROKE WHILE SCREWING INTO THE BONE. 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 18340778 ↗MalfunctionJul 13, 2021Break
IT WAS REPORTED THAT DURING A BIO TENODESIS PROCEDURE, THE AR-1580BC, SCREW TIP BROKE UPON INSERTION. THE FRAGMENT WAS RETRIEVED AND THE CASE WAS COMPLETED BY USING A NEW AR-1580BC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12162960 ↗InjuryAug 16, 2017Patient-Device Incompatibility
IT WAS REPORTED THAT THE TENODESIS SCREW WAS IMPLANTED ON THE (B)(6) 2017. AFTER 10 DAYS THE PATIENT COMPLAINED ABOUT EXTREME ITCHING OVER THE COMPLETE BODY. THE SITUATION HAS BEEN THE SAME OVER 7 WEEKS. THE PATIENT TAKES ANTIHISTAMINES WHICH HELP REDUCED THE ITCH. THE PATIENT ALSO RECEIVED CORTISONE FOR 6 DAYS WHICH ALSO DID NOT WORK TO REDUCE THE OVERALL REACTION. WHEN THE SURGEON MOVES THE OPERATED ARM OF THE PATIENT THE REDNESS WAS ENLARGING ON THE BODY.
Patient problems: Hypersensitivity/Allergic reaction; Inflammation
MAUDE report 6798303 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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