NA 2351-4280Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327368178), received between Jan 28, 2019 and Aug 6, 2026 — classified as 1 injury, 3 malfunctions.

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Off-Label Use

  As reported: "When inserting the proximal locking drill sleeve into the device, it was mistakenly inserted from lateral to medial instead of from medial to lateral as instructed, resulting in an unnecessary skin incision. The error was noticed before drilling was performed. The procedure was then continued using the correct technique, drilling from medial to lateral, and the surgery was completed without further issue."

  Patient problems: Perforation

  MAUDE report 50158517 ↗
• MalfunctionNov 7, 2023Crack; Crack

  IT WAS REPORTED THAT DURING CSSD WASHING THE ¿PLASTIC¿ SECTION OF THE SLEEVE WAS FOUND TO BE CRACKED AND SPLIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082274 ↗
• MalfunctionAug 15, 2023Naturally Worn; Naturally Worn

  AS REPORTED: "IT WAS CONFIRMED THAT THE 23514280 WAS WORN AND THE FIT WITH 23510070 WAS LOOSE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550453 ↗
• MalfunctionJan 28, 2019Break

  THE SURGEON WAS DOING A T2 ALPHA TIBIAL NAIL. THE BLACK MATERIAL SHEERED FROM THE CALIBRATED TROCAR (CAT # 2351-4280), WHILE ASSEMBLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283521 ↗