Arthrex® AR-8740-46PTSRecalls & reported problems
Arthrex, Inc. · QCKFIX SCRW,TI,CANN ST,CANC.,4.0X 46MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867046474), received between May 7, 2019 and May 7, 2019 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2019Break
IT WAS REPORTED DURING A SUBTALAR AND MIDFOOT FUSION PROCEDURE, WHILE IMPLANTING THE AR-8740-46PTS LOW PROFILE SCREW (LOT: 1051702), THE UPPER THIRD SHAFT OF THE SCREW BROKE OFF COMPLETELY. THE REP REPORTED THE BROKEN HEAD OF THE SCREW BROKE OUTSIDE OF THE BODY AND WAS FULLY RETRIEVED. THE REMAINING SHAFT OF THE SCREW WAS LEFT IMPLANTED. THE REP STATED ANOTHER SCREW WAS NOT BROUGHT IN, AND THE CASE PROCEEDED AS PLANNED. THE SURGEON USED TWO STAPLES LATERALLY TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THE REP STATED THE BROKEN PORTION OF THE SCREW WILL BE RETURNING FOR EVALUATION. TWO SCREWS WERE SUCCESSFULLY IMPLANTED PRIOR TO THE BREAKING OF THE THIRD AR-8740-46PTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8588384 ↗
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- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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