NA 03.311.058Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982078131), received between Jul 17, 2019 and Jul 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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. 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.

• MalfunctionJul 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, DURING LOAN KIT INSPECTION, AN INDENTED STOPS OF THE CANNULATED CLAMP-BOLT WERE NOTICED TO HAVE WORN OUT AND THE LOCKING COLLAR HAS COME OFF. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) SCHANZ SCREW BOLT CANNULATED RING MOUNT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8798664 ↗

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