NA 03.311.043Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982078049), received between Apr 18, 2019 and Apr 18, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K051600, K092190, K161417); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TWO (2) REDUCTION WIRE-LONG & FOUR (4)REDUCTION WIRE-HALF POINT TIP WERE OBSERVED BENT WHEN OPENING THE PACKAGE ON (B)(6) 2019. THE DEVICES NEVER MADE IT TO THE ACCOUNT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/2.0MM DIAMETER 400MM LONG. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8529863 ↗
• MalfunctionApr 18, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TWO (2) REDUCTION WIRE-LONG & FOUR (4) REDUCTION WIRE-HALF POINT TIP WERE OBSERVED BENT WHEN OPENING THE PACKAGE ON (B)(6) 2019. THE DEVICES NEVER MADE IT TO THE ACCOUNT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) REDUCTION WIRE/2.0MM DIAMETER 400MM LONG. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8529858 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051600, K092190, K161417. One submission often covers many models, so check the product and lot details in each record.

• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
• Z-1324-2009 · Feb 9, 2009 · Terminated
  Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure componen