NA 03.311.048Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982078070), received between Jan 18, 2019 and Apr 18, 2019 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 reports).

1 other recall cover devices cleared under the same FDA submission (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 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 DIA HALF POINT TIP. THIS IS REPORT 6 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8529904 ↗
• 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 DIA HALF POINT TIP. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8529898 ↗
• 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 DIA HALF POINT TIP. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8529885 ↗
• 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 DIA HALF POINT TIP. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8529878 ↗
• InjuryJan 18, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MAXFRAME FULL RING BROKE ON THE PATIENTS FRAME WHICH WAS BEING USED TO TREAT A DISTAL TIBIA FRACTURE. THE ORIGINAL IMPLANT PROCEDURE WAS ON (B)(6) 2018. THE BROKEN RING WAS REPLACED ON (B)(6) 2019, WITH A 150MM 5/8 RING AND BRIDGE PLATE. THE PATIENT ALSO BROKE TWO (2) SMOOTH WIRES AND ONE (1) OLIVE WIRES. THE WIRES WERE ALSO REPLACED WITH NEW ONES. IT IS UNKNOWN IT THERE WAS SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) REDUCTION WIRE 2.0MM DIA HALF POINT TIP. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8261153 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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.