Arthrex® AR-1927PNF-45Recalls & reported problems
Arthrex, Inc. · SUTURE ANCHOR, PEEK CORKSCREW · Class 2 · Implant
Data updated Oct 18, 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 00888867023611), received between Apr 3, 2024 and Apr 3, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2024Break; Break
ON 25TH MARCH 2024, IT WAS REPORTED BY A SALES REP. VIA EMAIL THAT FOR AN AR-1927PNF-45, 4.5 MM PEEK CORKSCREW® FT SUTURE ANCHOR WITH FOUR NEEDLES WITH ONE #1 FIBERWIRE® AND ONE #1 TIGERWIRE®, THE NURSE STATED THAT THE TIP OF THE CORKSCREW ANCHOR BROKE OFF WHEN MR .COLEMAN WAS SCREWING IT INTO THE BONE. THE SALES REP ASKED HER IF ALL THE CORRECT SETS WERE FOLLOWED TO PUT THE ANCHOR AND IN HER KNOWLEDGE IT WAS. THERE WAS NO SUPPORT AT THE CASE. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE BROKEN PIECES WERE REMOVED AND A NEW ANCHOR WAS INSERTED.
Patient problems: Insufficient Information
MAUDE report 19032431 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page