NA 04.124.418Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982111081), received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K110354); 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 16, 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.

• InjurySep 17, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY AND REVEALED THAT A TITANIUM ROD HAD BROKEN IN TFN. IT WAS REMOVED AND REPLACED BUT PATIENT STILL IN EXCRUCIATING PAIN. SHE HAD TO UNDERGO TWO ADDITIONAL CORRECTIVE SURGERIES. THE PATIENT WAS INVOLVED IN A MOTORCYCLE ACCIDENT ON (B)(6) 2016 AND SUFFERED FROM MULTIPLE INJURIES, INCLUDING FRACTURES TO BOTH HER RIGHT AND LEFT FEMURS AS WELL AS RIGHT HIP. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WHERE A TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM (TGH) AND ADDITIONAL MARKINGS CED/1233 AND 96898 WAS USED FOR INTRAMEDULLARY FIXATION OF HER RIGHT HIP AND FEMUR. THE PATIENT HAS BEEN MOSTLY CONFINED TO WHEELCHAIR SINCE THE ACCIDENT. SHE CONTINUES TO HAVE PAIN, BUT THE CORRECTIVE SURGERIES HAVE LESSENED HER PAIN. CONCOMITANT DEVICES REPORTED: 1.7MM CABLE WITH CRIMP 750MM (PART NUMBER 298.801, LOT P233138 , QUANTITY 3), 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM (PART NUMBER 02.231.265, LOT 9880865, QUANTITY 1), 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/70MM (PART NUMBER 02.231.270, LOT 9893051, QUANTITY 1), 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/70MM (PART NUMB

  Patient problems: No Code Available; Pain

  MAUDE report 10547062 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110354. One submission often covers many models, so check the product and lot details in each record.

• Z-1125-2014 · Feb 5, 2014 · Terminated
  Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plat
• Z-0401-2014 · May 29, 2013 · Terminated
  Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fra