Arthrex® AR-8935-20Recalls & reported problems
Arthrex, Inc. · LO-PRO SCRW,TI,3.5MMX 20MM · 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 00888867050464), received between Sep 14, 2017 and Jul 18, 2025 — 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
- Appropriate Device Problem Term/Code Not Available1
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2025Break; Break
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-8935-20 3.5 MM X 20 MM TITANIUM LOW-PROFILE SCREW HEAD BROKE OFF CLEANLY DURING USE. NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22542268 ↗MalfunctionNov 28, 2022Break; Entrapment of Device
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8935-20 LOW PROFILE SCREW HEAD BROKE WHILE ATTEMPTING TO DO THE FINAL TURN AFTER INSERTING IT INTO AN AR-9943T-06 LOCKING THIRD TUBULAR PLATE. THE HEAD OF THE SCREW WAS RETRIEVED; HOWEVER, THE BODY WAS ABLE TO HOLD THE REDUCTION OF THE FRACTION AND WAS LEFT IN THE PATIENT. NO ADDITIONAL SCREWS NEEDED TO BE USED. THIS WAS DISCOVERED DURING AN ANKLE FRACTURE PROCEDURE ON (B)(6) 2021.
Patient problems: Foreign Body In Patient
MAUDE report 15870789 ↗InjurySep 14, 2017Appropriate Device Problem Term/Code Not Available
IT WAS ORIGINALLY REPORTED THAT THE SCREWS BEGAN TO CHANGE ANGLE AFTER BEING IMPLANTED. FOLLOW-UP INVESTIGATION: IT WAS REPORTED THAT THE PATIENT UNDERWENT DISTAL RADIUS REPAIR ON (B)(6) 2017. ON (B)(6) 2017 THE PATIENT WAS EXPERIENCING PAIN AND DISPLACEMENT. THE VOLAR DISTAL RADIUS PLATE ALONG WITH ALL THE SCREWS WERE REMOVED ON (B)(6) 2017. THE ISSUE WAS FOUND DURING ROUTINE FOLLOW UP WITH X-RAYS. NO ARTHREX DEVICES WERE IMPLANTED DURING REVISION SURGERY.
Patient problems: Joint Dislocation; Pain
MAUDE report 6864202 ↗
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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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