Arthrex® AR-8935L-26SRecalls & reported problems
Arthrex, Inc. · LOW PROFILE LOCKING SCREW 3.5 MM X 26 MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867050983), received between Jun 20, 2025 and Sep 11, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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.
Reports received per month
Most reported problems
Device problems
- Incomplete or Inadequate Connection1
- Positioning Failure1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Incomplete or Inadequate Connection
On 28th August 2026, it was reported by an Arthrex employee via email that for an AR-8935L-26S, Low Profile Locking Screw, Titanium, 3.5 x 26 mm, sterile, IM, it failed to lock with the plate. This was detected during use in an unknown procedure on (b)(6) 2026. The procedure was completed successfully after confirming the attachment of the locking drill sleeve, a new screw of the same length was used to achieve locking.No significant surgery delay reported. No additional anesthesia administered to the patient.
Patient problems: Insufficient Information
MAUDE report 50731817 ↗MalfunctionJun 20, 2025Positioning Failure; Positioning Failure
ADDITIONAL INFORMATION WAS RECEIVED ON 06/25/2025: THERE WERE NO REPORTS OF ANY DEVICE BREAKAGE INSIDE THE PATIENT. THE PROCEDURE PROCEEDED WITHOUT DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE AR-8943-42 WAS USED TO PREPARE THE BONE SOCKET FOR IMPLANT INSERTION, AND THE PATIENT'S BONE QUALITY WAS ASSESSED AS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED ON 07/02/2025: THE CORRECT PLATE PART USED IN THE PROCEDURE WAS AR-8954PL-XSS CALCANEAL FRACTURE PERIMETER PLATE FROM LOT 15040619.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22297736 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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