NA 02.231.224Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982062048), received between Oct 11, 2019 and Apr 14, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K083025, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON SEPTEMBER 24, 2020 THE PATIENT HAD A FALL AND SUSTAINED A PERIPROSTHETIC FEMUR FRACTURE REQUIRING OPEN REDUCTION INTERNAL FIXATION (ORIF). THE PLATE AND SCREWS WERE MANUFACTURED BY SYNTHES. IMPLANTS DID NOT APPEAR TO BE REMOVED. ON (B)(6) 2021 X-RAY TAKEN SHOWED PERSISTENT DISPLACEMENT OF A PARTIALLY HEALED DISTAL FEMUR FRACTURE WITH LATERAL PLATE AND SCREW CONSTRUCT STABLE IN POSITION. ON (B)(6), 2021 INJECTION TO LEFT KNEE FOR PAIN PERFORMED. PAIN HAS PERSISTED DESPITE PHYSICAL THERAPY, BRACING, AND NERVE BLOCKS. ON (B)(6) 2021: SURGEON STATEED THAT THE LEFT KNEE IS LIGAMENTOUSLY LOOSE TO VARUS STRESS AND PAIN ON (B)(6), 2021 X-RAY RESULTS STATED THAT THERE IS A PERIPROSTHETIC FRACTURE IN THE DISTAL FEMORAL DIAPHYSIS THAT IS SUBACUTE TO CHRONIC. THERE IS ONE SHAFT WIDTH POSTERIOR DISPLACEMENT OF THE DISTAL FRACTURE FRAGMENT. THERE IS NO EVIDENCE OF HARDWARE FRACTURE OR LOOSENING. SURGEON STATES LEFT KNEE IS UNSTABLE LIKELY SECONDARY TO MALUNION OF THE FEMUR FRACTURE WITH RESULTANT SHORTENING. ON (B)(6) 2021: PATIENT SUSTAINED TWO FALLS RESULTING IN A PELVIC AND THEN A RIGHT HUMERAL FRACTURE. MEDICAL RECORDS DO NOT INCLUDE THE PRIMARY OPERATIVE NOTES, NOR T

  Patient problems: Bone Fracture(s); Malunion of Bone; Pain

  MAUDE report 16747806 ↗
• MalfunctionOct 11, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE VARIABLE ANGLE LOCKING SCREW WAS RECEIVED WITH A WHITE SUBSTANCE INSIDE THE THREAD OF THE LOCKING SCREW. THE PRODUCT HAS NOT BEEN OPENED BECAUSE IT WAS NOTED THE SIDE BEFORE THE PACKAGE WAS BEING OPENED. THE SCREW WAS NOT PUT INTO THE PATIENT OR EVEN INTO A SET. THERE WAS NO PATIENT INVOLVEMENT REPORTED. DURING MANUFACTURER'S INVESTIGATION ON (B)(6) 2019 OF THE RETURNED DEVICE IT WAS NOTED THAT NO WHITE SUBSTANCES ON THE THREADS OF THE SCREW, INSTEAD THERE APPEARS BE SOME STRIPPED THREADS ALONG THE HEAD AND TOP PORTION OF THE SHAFT. ADDITIONALLY, THE SCREW HAS LOST SOME ITS LUSTER WHICH MAY HAVE BEEN WHAT THE COMPLAINT DESCRIPTION WAS DESCRIBING. THIS REPORT IS FOR ONE (1) 5.0MM VARIABLE ANGLE LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9181428 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083025, 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