Arthrex® AR-8933VCL-20Recalls & reported problems
Arthrex, Inc. · VAL KreuLock Screw, Ti, 3.0x20 · 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 00888867324213), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ON 16TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-9944S-0R, MAXFORCE¿ MTP COMPRESSION PLATE, STD, 0° VALGUS, 0° DORSIFLEX, RIGHT AND AN AR-8933VCL-20, KREULOCK¿ COMPRESSION SCREW, TI, 3 MM X 20 MM, DURING THE INSERTION OF THE 3MM KRUELOCK SCREW, IT FELL THROUGH THE PLATE AND WAS NOT ENGAGING THE LOCKING THREAD. THE SCREW WAS CHECKED TO CONFIRM 3MM FITTING ON T10 SCREWDRIVER. 2MM DRILL WAS USED THROUGH FIXED LOCKING TOWER. THE SURGEON WAS UNABLE TO REMOVE SCREW AND IT REMAINS IN PATIENT. THIS WAS DETECTED DURING USE IN AN UNSPECIFIED PROCEDURE ON 1(B)(6) 2025. ON (B)(6) 2025: THE COMPLAINT INITIATOR REPLIED THAT THIS WAS DETECTED DURING USE IN A MTPJ FUSION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025: THE COMPLAINT INITIATOR REPLIED WITH THE BATCH NUMBERS HOWEVER, FOR AR-8933VCL-20, THE COMPLAINT INITIATOR IS UNSURE WHICH WAS THE BATCH NUMBER OF THE DEFECTIVE SCREW AS 2 AR-8933VCL-20 WERE USED BUT THE COMPLAINT INITIATOR COULD NOT IDENTIFY WHICH ONE OF THE TWO SCREWS WAS RELATED TO THE DEFECT COMPLAINT.
Patient problems: Foreign Body In Patient
MAUDE report 22440605 ↗
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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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