NA 294.57Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982181596), received between Jul 21, 2022 and Jul 21, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K082650, K122455, K161417, K950384); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Break; Break

  DEVICE REPORT FROM CHILE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE ICU OF THE HOSPITAL, WITH FOUR BROKEN SCHANZ SCREWS. THE PATIENT WAS ADMITTED IN A STATE OF COMPROMISED CONSCIOUSNESS, THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 250MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15073947 ↗
• InjuryJul 21, 2022Break; Break

  DEVICE REPORT FROM CHILE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT WAS ADMITTED TO THE ICU OF THE HOSPITAL, WITH FOUR BROKEN SCHANZ SCREWS. THE PATIENT WAS ADMITTED IN A STATE OF COMPROMISED CONSCIOUSNESS, THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 250MM. THIS IS REPORT 3 OF 4 FOR PC-(B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15073946 ↗
• InjuryJul 21, 2022Break; Break

  DEVICE REPORT FROM CHILE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE ICU OF THE HOSPITAL, WITH FOUR BROKEN SCHANZ SCREWS. THE PATIENT WAS ADMITTED IN A STATE OF COMPROMISED CONSCIOUSNESS, THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 250MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15073945 ↗
• InjuryJul 21, 2022Break; Break

  DEVICE REPORT FROM CHILE REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE ICU OF THE HOSPITAL, WITH FOUR BROKEN SCHANZ SCREWS. THE PATIENT WAS ADMITTED IN A STATE OF COMPROMISED CONSCIOUSNESS, THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR A 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 250MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15073913 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082650, K122455, K161417, K950384. 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.