NA 03.211.430Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982076366), received between Mar 19, 2020 and Aug 11, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 11, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE CALCANEAL FRACTURE WITH THE COMPRESSION WIRE IN QUESTION. DURING THE SURGERY, WHEN THE SPHERICAL STOP PART OF THE COMPRESSION WIRE TOUCHED THE PLATE, THE WIRE BROKE AT THE THREAD PART. THE THREAD PART WAS BURIED IN THE BONE AND WAS REMOVED WITH MEDICAL INSTRUMENTS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FORTY(40) MINUTES. CONCOMITANT DEVICE REPORTED: UNK: PLATES: VA-LIF: VARIABLE ANGLE LOCKING INTERCARPAL FUSION PLATE(PART#UNKNOWN; LOT# UNKNOWN; QUALITY:UNK). THIS REPORT IS FOR ONE (1) 1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308522 ↗
• MalfunctionApr 5, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE TORQUE LIMITING ATTACHMENT WOULD NOT LIMITING AND THE THREADED REDUCTION WIRE BROKE OFF AT THE OLIVE. PLIERS WERE USED TO REMOVE THE WIRE AND THE SURGICAL PROCEDURE WAS DELAYED FOR TWO (2) MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612707 ↗
• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING INSERTION THE COMPRESSION WIRE BROKE OFF AT THE BALL. BROKEN FRAGMENTS WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.6MM COMPRESSION WIRE 30MM THREAD/150MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9855564 ↗