NA 02.211.411Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982055002), received between Mar 23, 2020 and Aug 4, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR A LEFT EXTRA-ARTICULAR FRACTURE WITH A VA LOCKING CALCANEAL PLATE ON AN UNKNOWN DATE. SEVEN SCREWS WERE USED FOR FIXATION. HARDWARE REMOVAL WAS PERFORMED AT 14 MONTHS POSTOPERATIVELY DUE TO PLATE PROMINENCE.

  Patient problems: Insufficient Information

  MAUDE report 17461786 ↗
• MalfunctionFeb 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, RETENTION PIN SCREWDRIVER STRIPPED, VARIABLE ANGLE (VA) ANTEROLATERAL CALCANEAL LOCKING PLATE HOLE WAS STRIPPED, VARIABLE ANGLE (VA) SPHERICAL DRILL GUIDE IS STRIPPED, PROXIMAL TIBIAL PLATE STERILE BOXED PLATE HAD A STAIN. THE TROCAR WITH HANDLE BUTTON WAS STRIPPED AND THE INTER-LOCK SCREWDRIVER BROKE OFF WHEN TRYING TO DETACH THE SCREW. THERE WAS A SURGICAL DELAY OF UNKNOWN MINUTES. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). SCRWDRVR F/4.5MM TI MULTILOC SCREWS/SLF-RETAIN/330MM (PART NUMBER 03.019.025, LOT UNKNOWN, QUANTITY 1). 3.5MM PROXIMAL TIBIA PLATE 6 HOLES/RIGHT-STERILE (PART NUMBER 241.006S, LOT UNKNOWN, QUANTITY 1). 4.3MM VA SPHERICAL DRILL GUIDE LONG F/5.0MM VA LCKNG SCREWS (PART NUMBER 03.231.008, LOT UNKNOWN, QUANTITY 1). TROCAR WITH HANDLE FOR USE WITH 03.120.014 (PART NUMBER 03.120.015, LOT UNKNOWN, QUANTITY 1) INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM (PART NUMBER 03.010.473, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM VA-LCKING ANTEROLATERAL CALCANEAL PL SHORT 40MM LEFT. THIS IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345021 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON PERFORMED A HARDWARE REMOVAL DUE TO PAIN ON A CALCANEUS, EVERYTHING CAME OUT SUCCESSFULLY AND REMOVAL WAS DONE. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS 1 OF 7 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 9868889 ↗