Arthrex® AR-8933L-16Recalls & reported problems
Arthrex, Inc. · LO-PRO LOCK SCRW,TI,3.0MMX 16MM · 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 00888867050044), received between Dec 15, 2016 and Dec 15, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
- Failure To Adhere Or Bond1
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.
InjuryDec 15, 2016Failure To Adhere Or Bond; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A PREVIOUS 2ND TMT FUSION ON (B)(6) 2015. THE SURGEON WAS PERFORMING A 2ND TMT FUSION REVISION SURGERY ON (B)(6) 2016 DUE TO NON-UNION DURING WHICH THE FOLLOWING DEVICES WERE EXPLANTED: AR-8952TT-04, LOT 6791406 (CC100071 LINE (B)(4)), AR-8933L-24, LOT W38572 (CC100071 LINE (B)(4)), AR-8933L-16, LOT 1437750 (CC100071 LINE (B)(4)), AR-8933-26, LOT 157946 (QTY 2) (CC100071 LINE (B)(4)) AND AR-8933-28, LOT 139580 (CC100071 LINE (B)(4) ). TO COMPLETE THE REVISION PROCEDURE THE SURGEON WAS IMPLANTING AN AR-8952MS-07, 2.4MM 7 HOLE LOW PROFILE STRAIGHT PLATE (CC100071 LINE(B)(4)) ALONG WITH AN AR-8724L-18, 2.4MM X 18MM LOW PROFILE LOCKING SCREW (CC100071 LINE (B)(4)) WERE BEING IMPLANTED IN THIS REVISION SURGERY. A 1.7MM DRILL WAS USED TO CREATE THE PILOT HOLES FOR THE SCREWS. THE SURGEON SECURED THE PLATE WITH BB TAKS. HE THEN INSERTED A 2.4MM LOCKING SCREW, AND THE SCREW HAD CUT THROUGH THE PLATE AND DID NOT LOCK IN. THE 2.4MM PLATE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 3.0 MM STRAIGHT MTP PLATE AND SCREWS. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6178008 ↗
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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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