Arthrex® AR-1547PSRecalls & reported problems
Arthrex, Inc. · TENO SCRW,PEEK,VENT · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867018785), received between Mar 8, 2021 and Dec 8, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break3
- Crack1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- 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.
MalfunctionDec 8, 2023Break; Break
IT WAS REPORTED THAT DURING A SURGERY THE IMPLANT WAS FOUND TO BE BROKEN. THE SURGEON REPORTED THAT THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. (B)(6) 2021 UPDATE DW FURTHER INFORMATION WAS PROVIDED THAT THE IMPLANT CRACKED WHILE THE SURGEON TRIED TO IMPLANT IT. NOTHING BROKE OFF FROM THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18296601 ↗MalfunctionJun 28, 2021Break
IT WAS REPORTED THAT THE AR-1547PS SCREW WAS BEING USED FOR AN LRTI. DURING IMPLANT, THE SCREW BROKE UP INTO PARTS. ALL THE PARTS WERE RETRIEVED FROM THE PATIENT AND ANOTHER AR-1547PS WAS USED TO COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 12076006 ↗MalfunctionMar 8, 2021Break; Crack
IT WAS REPORTED THAT UPON INSERTING THE AR-1547PS, 4.75 PEEK TENODESIS SCREW INTO BONE THE LEADING THREADS STARTED TO CRACK ON THE SCREW. THE SURGEON APPARENTLY NOTICED AT THIS POINT, BACKED OUT THE SCREW AND OPENED A NEW SCREW WHICH WENT IN NO PROBLEM. THE SURGERY WAS COMPLETED WITH NO ISSUES TO THE PATIENT OR WITH ANY OTHER PRODUCTS. THE BONE QUALITY WAS HARD. THE REP REPORTED A SMALL PIECE OF THE FIRST THREAD OF THE SCREW BROKE OFF. THE REP STATED THE SURGEON DID NOT MAKE ANY MENTION OF AN UNRETRIEVED FRAGMENT.
Patient problems: Foreign Body In Patient
MAUDE report 11435906 ↗
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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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