Arthrex® AR-1360BRecalls & reported problems
Arthrex, Inc. · BIO-INTERF SCRW W/DISP SHTH · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867013995), received between Jun 14, 2018 and Jun 14, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2018Break
IT WAS REPORTED THAT THE SURGEON SCREWED IN THE TIBIAL SCREW AR-1360B DURING AN ACL OPERATION, WHEN THE SCREWDRIVER WAS KNOCKED OUT, THE SCREW BROKE AND GOT STUCK ON THE SCREWDRIVER, IT WAS NOT REMOVED FROM THE SCREWDRIVER AR-1386. THERE WAS NO HARM FOR THE 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. FOLLOW-UP INVESTIGATION: THE BROKEN PART OF THE SCREW IS STUCK ON THE SCREWDRIVER AND HAS BEEN REMOVED FROM THE PATIENT'S BODY. THE OTHER PART OF THE BROKEN SCREW IS STUCK IN THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600195 ↗
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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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