VA-LCP 04.117.401SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982106094), received between Apr 10, 2024 and Apr 10, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K120070); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A TRANSCONDYLAR FRACTURE OF THE DISTAL HUMERUS. AFTER IMPLANTING A POSTERIOR LATERAL PLATE, THE SURGEON BEGAN IMPLANTING THE MEDIAL PLATE, BUT THREE SCREWS IDLED AND NO TORQUE COULD BE APPLIED. THE FIRST SCREW WAS INSERTED AFTER DRILLING USING A 2.7 VA DRILL GUIDE, BUT THE SCREW IDLED WHEN THE HEAD CAME NEAR TO THE PLATE. THIS SCREW WAS REMOVED BECAUSE A METAL FRAGMENT WAS GENERATED. THE SECOND SCREW WAS INSERTED INTO THE SAME HOLE AS THE FIRST, BUT IT ALSO IDLED. TORQUE COULD BE LIGHTLY APPLIED TO THIS SCREW SO IT WAS LEFT IN THE HOLE. THE THIRD SCREW WAS INSERTED INTO ANOTHER HOLE AFTER DRILLING WITH THE VA DRILL GUIDE, BUT NO TORQUE COULD BE APPLIED. THIS SCREW WAS ALSO LEFT IN THE HOLE. ANOTHER DRILL GUIDE WAS USED AND THE ISSUES WITH SCREW IDLING AND LACK OF TORQUE WERE RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO ADVERSE PATIENT IMPACT, IT WAS CONFIRMED VIA X-RAY THAT NO FRAGMENTS REMAINED WITHIN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7/3.5MM TI VA-LCP MEDL DSTL HUM PL/1H/RT/69MM-SHORT-STE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080483 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120070. One submission often covers many models, so check the product and lot details in each record.

• Z-0124-2016 · Sep 28, 2015 · Terminated
  Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes