NA 02.111.501.10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20886982031706), received between Nov 30, 2017 and Jul 21, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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 18, 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.

• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED BY THE SURGEON THAT THE PLATE REDUCTION WIRE BROKE OFF JUST DISTAL TO THE METAL BALL ON THE WIRE AS HE WAS INSERTING IT INTO THE K-WIRE HOLE IN THE PLATE. THIS RESULTED IN THE TIP OF THE WIRE BEING STUCK IN THE PLATE. THE SURGEON ELECTED TO REMOVE THE PLATE FROM THE WOUND AND SELECTED A DIFFERENT PLATE. PROCEDURE WAS COMPLETED WITH A DELAY OF 2 MINUTES. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555116 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, A PLATE REDUCTION WIRE BROKE AND FRAGMENTS WERE GENERATED. THE PLATE REDUCTION WIRE AND FRAGMENTS WERE REMOVED EASILY WITH NO ADDITIONAL INTERVENTION. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT STATUS WAS REPORTEDLY SATISFACTORY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7679118 ↗
• MalfunctionJun 26, 2018Break; Break

  IT WAS REPORT THAT DURING AN ORIGINAL SURGERY ON (B)(6) 2018 FOR TREATMENT OF A DISTAL RADIUS FRACTURE, PATIENT WAS IMPLANTED WITH ONE (1) 2.4MM VARIABLE ANGLED LOCKING COMPRESSION PLATE (VA LCP) PLATE AND SIX (6) UNKNOWN SCREWS. THE SCREWS WERE A COMBINATION OF BOTH CORTEX AND VA LOCKING SCREWS. IT IS NOT KNOWN HOW MANY OF EACH WAS IMPLANTED. DURING THE PROCEDURE, WHILE THE SURGEON WAS USING THE 1.25MM PLATE REDUCTION WIRE TO SECURE THE PLATE FOR CORRECT BONE REDUCTION, THE REDUCTION WIRE BROKE IN HALF, INTO TWO PIECES. THE WIRE BROKE OFF RIGHT ABOVE THE PLATE REDUCTION DEVICE. A PIECE OF THE WIRE WAS TEMPORARILY INSIDE THE PATIENT, BUT WAS SUCCESSFULLY REMOVED. SURGEON REMOVED THE WIRE AND CHOSE ANOTHER ONE THAT WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE BONE FIXATION. SURGERY WAS COMPLETED SUCCESSFULLY WITH A TWO (2) MINUTE TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 2.4MM VA LCP DORSAL DISTAL RADIUS PLATE (PRODUCT NUMBER 02.115.540, LOT NUMBER UNKNOWN, QUANTITY 1), CORTEX SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7639626 ↗
• MalfunctionNov 30, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF GUIDE WIRE BROKE OFF DURING A RIGHT ORIF DISTAL SURGERY. THE BROKE PIECE WAS RETRIEVED AND OUTCOME WAS NOT AFFECTED. CONCOMITANT DEVICE REPORT: [UNKNOWN WIRE DRIVER] (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1) AND [2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/3H SHAFT/RIGHT] (PART #: 02.111.630, LOT #: UNKNOWN, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7072474 ↗