Arthrex® AR-1555PSRecalls & reported problems
Arthrex, Inc. · TENO SCRW,PEEK,VENT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867018877), received between Jan 12, 2026 and Jan 12, 2026 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2026Break
ON 29-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE THREADS OF AN AR-1555PS PEEK TENODESIS SCREW (5.5 X 15 MM) SEPARATED DURING INSERTION. THE CASE WAS COMPLETED BY OPENING A SECOND SCREW, WHICH WAS INSERTED WITHOUT ISSUE. THIS OCCURRED DURING A LATERAL ANKLE RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 31-DEC-2025: DURING INSERTION, THE THREADS OF AN AR-1555PS PEEK TENODESIS SCREW (5.5 X 15 MM) SEPARATED AND BROKE OFF INSIDE THE PATIENT. ALL FRAGMENTS WERE RETRIEVED. THE CASE WAS DELAYED APPROXIMATELY FIVE MINUTES, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THE PROCEDURE WAS COMPLETED USING A NEW AR-1555PS PEEK TENODESIS SCREW (5.5 X 15 MM). NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24043569 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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