Arthrex® AR-7000-34Recalls & reported problems
Arthrex, Inc. · CANN SCRW,3.75X 34MM PT THRDED · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867041042), received between Jan 27, 2017 and Jan 27, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
Patient problems
- No Code Available1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2017Break
IT WAS REPORTED THAT TEN DAYS POST-OP FROM A LATERJET PROCEDURE, THE PATIENT WAS SEEN FOR A POST-OP FOLLOW-UP VISIT UP AND IT WAS NOTICED THAT THE AR-7000-34, 3.75MM X 34MM PARTIALLY THREADED CANNULATED SCREW HAD BROKEN. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017 TO EXPLANT THE BROKEN SCREW. THE EXPLANTED SCREW WAS REPLACED WITH ANOTHER MANUFACTURER'S SCREW.
Patient problems: No Code Available
MAUDE report 6282313 ↗InjuryJan 27, 2017Break
IT WAS REPORTED THAT TEN DAYS POST-OP AFTER A LEFT LATERJET PROCEDURE, PATIENT WAS SEEN BY SURGEON FOR A POST-OP CHECK UP WITH COMPLAINTS OF PAIN IN THE LEFT SHOULDER. FILMS WERE TAKEN AND IT WAS DISCOVERED THAT THE AR-7000-34, 3.75X34MM PARTIALLY THREADED CANNULATED SCREW ((B)(6) (B)(6)) WAS BROKEN INTO TWO PIECES. REVISION SURGERY TOOK PLACE THE FOLLOWING DAY WHERE THE SURGEON EXPLANTED THE TWO PIECES OF THE 3.75X34MM PARTIALLY THREADED CANNULATED SCREW ((B)(4)). A 3.75X32MM PARTIALLY THREADED CANNULATED SCREW ((B)(6) (B)(4)) WAS ALSO REMOVED BUT WAS NOT BROKEN. THE SURGEON REPLACED BOTH WITH A SECOND 3.75X34MM PARTIALLY THREADED CANNULATED SCREW AND A SECOND 3.75X32MM PARTIALLY THREADED CANNULATED SCREW. NO LOT INFORMATION WAS AVAILABLE.
Patient problems: Pain
MAUDE report 6282311 ↗
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