Arthrex® AR-1562BCRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867018907), received between Feb 28, 2022 and Jun 5, 2025 — classified as 3 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
- Positioning Failure1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Break; Break
IT WAS REPORTED THAT DURING A FLEXOR DIGITORUM LONGUS (FDL) TENDON TRANSFER, THE HEAD OF THE SCREW BROKE DURING INSERTION. THIS OCCURRED TWO TIMES DURING THE SURGERY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22148929 ↗MalfunctionOct 2, 2024Positioning Failure; Positioning Failure
ON 9/24/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1562BC BIOCOMPOSITE-TENODESIS SCREW WOULD NOT ARTICULATE THROUGH THE TISSUE. THIS WAS DISCOVERED DURING A PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20353640 ↗MalfunctionFeb 28, 2022Break
IT WAS REPORTED THAT DURING A BICEPS TENDON, BICEPS TENODESIS SHOULDER SURGERY THE SCREW WAS COMPLETELY CRUMBLED AFTER THE SECOND THREAD. THE CRUMBLED SCREW REMAINS IN PATIENT. 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 10-FEB-2022: THE SCREW PARTS WERE RECOVERED. AFTER THE SCREW HAD ALREADY SHATTERED ON THE SECOND TURN, THEY GOT THE REST OUT OF THE HOLE AND USED A NEW ONE.
Patient problems: Insufficient Information
MAUDE report 13620219 ↗
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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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