NA 294.785SHARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982182180), received between Jan 3, 2023 and Jan 3, 2023 — classified as 2 injuries.

5 other recalls cover devices cleared under the same FDA submission (K040701, K082650, K122455, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT PRIMARY SURGERY FOR CORRECTION OF BONY OR SOFT TISSUE DEFORMITIES. HA SCHANZ SCREWS WERE USED IN CONJUNCTION WITH MAXFRAME. THE PATIENT EXPERIENCE POSTOPERATIVE INFECTION. THE PATIENT HAD A SEGMENTAL TIBIA FRACTURE, FIXATED WITH MAXFRAME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM SELF-DRILLING SCHANZ SCREW 175MM/HA COATING-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 16088581 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR THE CORRECTION OF BONY OR SOFT TISSUE DEFORMITIES. THIS WAS THE PRIMARY SURGERY. HA SCHANZ SCREWS WERE USED IN CONJUNCTION WITH MAXFRAME. THE PATIENT EXPERIENCED A POSTOPERATIVE INFECTION AT THE OPERATIVE SITE TWO MONTHS AFTER SURGERY. THIS LED TO A BELOW THE KNEE AMPUTATION SECONDARY TO SEPTICEMIA. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM SELF-DRILLING SCHANZ SCREW 175MM/HA COATING-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 16088089 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040701, K082650, K122455, K161417. One submission often covers many models, so check the product and lot details in each record.

• Z-2451-2015 · Jul 29, 2015 · Terminated
  Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as th
• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
• Z-0941-2013 · Jan 11, 2013 · Terminated
  Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone
• Z-1816-2013 · Oct 12, 2012 · Open, Classified
  Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatme
• Z-0277-2013 · Sep 28, 2012 · Terminated
  Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation.