Arthrex® AR-18716V-10Recalls & reported problems
Arthrex, Inc. · VAL Screw, Ti, 1.6 x 10mm · 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 00888867313675), received between Dec 21, 2020 and Dec 21, 2020 — 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
- Material Twisted/Bent1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2020Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING A RIGHT HAND ORIF OF 4TH AND 5TH METACARPAL FRACTURES PROCEDURE THE SURGEON WAS USING THE ARTHREX MINI COMPREHENSIVE FIXATION SYSTEM AR-18700FS. WHEN SURGEON WAS REDUCING THE 4TH METACARPAL FX THE POINT-TO-POINT CLAMP TIPS ON THE AR-18700-45 BENT. ANOTHER ISSUE OCCURRED WHEN HE WAS PLATING THE 5TH METACARPAL LATER IN THE CASE. HE WAS USING THE DEPTH GAUGE AR-18700-27 (FROM THE AR-18700FS) TO MEASURE THE LENGTH OF THE SCREW AND THE DEPTH GAUGE PIN ASSEMBLY BENT IN MULTIPLE DIRECTIONS. THERE WAS ANOTHER ISSUE WITH TWO OF THE VAL 1.6MM SCREWS THAT WERE PLACED IN THE PLATE LOCATED ON THE 5TH METACARPAL. WHEN ADVANCING A 1.6 X 09MM SCREW, AR-18716V-09, THE SCREW HEAD SNAP OFF THE SCREW BEFORE THE THREADS OF THE LOCKING HAD EVER ENGAGED WITH THE PLATE. THIS HAPPENED IN THE EXACT SAME WAY WITH A 1.6 X 10MM SCREW, AR-18716V-10. THE SCREW THREADS THAT HAD MADE IT THROUGH THE PLATE AND THAT WERE ADVANCED INTO THE BONE WERE LEFT IN THE PATIENT'S BONE. ADDITIONAL INFORMATION OBTAINED 11/30/2020: THE AR-18700-45 AND AR-18700-27 WERE FROM THE AR-18700FS INSTRUMENT SET. THE TWO INSTRUMENTS WILL BE RETURNED FOR EVALUATION. THE PROXIMAL ENDS OF THE AR-18716V-09 AND AR-18
Patient problems: Failure of Implant
MAUDE report 11046363 ↗
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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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