Arthrex® AR-9094-090Recalls & reported problems
Arthrex, Inc. · Telescoping lag screw, 10.5 mm x 90 mm · 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 00888867409996), received between Feb 26, 2025 and Mar 30, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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
- Physical Resistance/Sticking3
- Break1
Patient problems
- Insufficient Information2
- Failure of Implant1
- 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.
InjuryMar 30, 2026Physical Resistance/Sticking
IT WAS REPORTED THAT DURING THE NAILING OF THE PROXIMAL FEMUR ON (B)(6) 2026, THE TELESCOPING LAG SCREW WAS INSERTED INTO THE BONE AT THE WRONG ANGLE. DUE TO THIS FAILURE THE SURGEON ATTEMPTED TO REMOVE THE SCREW, HOWEVER DUE TO THE INCORRECT INSERTION THE SCREW BECAME JAMMED. THE SURGEON DECIDED THAT THE FIXATION SHOULD BE SUFFICIENT AND THEREFORE THE SCREW WAS LEFT IN PLACE. IT WAS FURTHER REPORTED THAT DURING THE ATTEMPT OF REMOVING THE SCREW, THE INSTRUMENTS USED WERE BENT AS WELL. NOT LONG AFTER THE INITIAL SURGERY, IT WAS DISCOVERED THAT THE IMPLANTED DEVICE HAD FAILED AND THE NAIL HAD DETACHED FROM THE BONE. FOR THIS REASON, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DURING WHICH ALL PARTS WERE REPLACED WITH NEW DEVICES WITH THE SAME PART NUMBERS. EXCEPT THE SURGEON DECIDED TO USE A NAIL WITH A LONGER SHAFT TO ENSURE PROPER FIXATION. THE REVISION SURGERY WAS PERFORMED SUCCESSFUL, AND NO FURTHER ACTION IS PLANNED.
Patient problems: Failure of Implant
MAUDE report 24711887 ↗MalfunctionMar 21, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 3/4/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-9094-090 TELESCOPING LAG SCREW WOULD NOT COLLAPSE AFTER REMOVING THE TELESCOPING ACTUATOR. THE SCREW WAS REMOVED AND REPLACED WITH A NEW SCREW. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. NO FURTHER. INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED ON 3/12/2025.
Patient problems: Insufficient Information
MAUDE report 21663435 ↗MalfunctionFeb 26, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
ON 01/29/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN 9094-090 TELESCOPING LAG SCREW FELL APART DURING INSERTION. A C-ARM WAS BEING USED DURING THE PROCEDURE; HOWEVER, NO FRAGMENTS WERE SEEN ON THE X-RAY. THIS WAS DISCOVERED DURING A PROCEDURE IN (B)(6) 2025. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 02/06/2025: THIS WAS DISCOVERED DURING A HIP TROCHANTERIC NAIL PROCEDURE ON (B)(6) 2025. A PIECE OF THE LAG SCREW BROKE DURING INSERTION. THE SCREW WAS REMOVED AND REPLACED WITH A NEW ONE TO COMPLETE THE CASE. AN X-RAY CONFIRMED THAT NO FRAGMENTS WERE LEFT BEHIND.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21468672 ↗
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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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