NA 390.012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982197894), received between Jun 26, 2020 and Nov 17, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K043039, K082650, K122455); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LARGE EX-FIX 30° OUTRIGGER POST 11MM BROKE OFF WHILE ON THE PATIENT. IT BROKE OFF AFTER IT HAD BEEN IMPLANTED IN PATIENT. I BELIEVE THE IMPLANT BROKE AFTER BEING IMPLANTED FOR MULTIPLE WEEKS. WHEN IT BROKE THE PATIENT CONTACTED THE SURGEON AND THE REST OF THE FIXATION DEVICE WAS REMOVED IN CLINIC. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) LARGE EX-FIX 30° OUTRIGGER POST 11MM / MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10853235 ↗
• InjuryJun 26, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE DEVICE BREAKAGE. THE PORTION OF THE OUTRIGGER CLAMP THAT SCREWS INTO THE LARGE PIN CLAMP SNAPPED OFF 3 AND A HALF MONTHS POSTOPERATIVE. INITIALLY, THE REPORTED DEVICES WERE IMPLANTED LAST (B)(6) 2020. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS WAS STABLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10201675 ↗
• InjuryJun 26, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE DEVICE BREAKAGE. THE PORTION OF THE OUTRIGGER CLAMP THAT SCREWS INTO THE LARGE PIN CLAMP SNAPPED OFF 3 AND A HALF MONTHS POSTOPERATIVE. INITIALLY, THE REPORTED DEVICES WERE IMPLANTED LAST (B)(6) 2020. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SURGICAL DELAY. PATIENT STATUS WAS STABLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10201657 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043039, K082650, K122455. 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.