NA 294.55Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982181558), received between Apr 4, 2022 and Mar 12, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE STERILE PROCESSING DEPARTMENT (SPD) STAFF THAT ON (B)(6) 2024, THE WING NUT WAS BROKEN INSIDE THE SLEEVE WHILE ENGAGED WITH THE SCHANZ PIN. THE SCHANZ PIN COULD NOT BE REMOVED FROM THE SLEEVE. IT WAS UNKNOWN WHEN THE INSTRUMENT WAS BROKEN. THIS REPORT IS FOR ONE (1) 5.0 SCHANZ SCR BLUNTED TROCAR POINT 170 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885565 ↗
• MalfunctionApr 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A ORIF OF PROXIMAL TIBIA PROCEDURE. IT WAS NOTED THAT THE THREADS OF A WING NUT BROKE OFF IN ITEM HOLDING SLEEVE 105MM WHILE THE SURGEON WAS TIGHTENING IT. THERE WAS NO HARM DONE TO THE PATIENT AND WE WERE ABLE TO PROCEED WITH THE PROCEDURE WITH NO SURGICAL DELAY AND NO FURTHER ISSUES. PATIENT OUTCOME IS REPORTED AS DOING WELL. DURING MANUFACTURER'S PRELIMINARY EVALUATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT A 5.0MM SCHANZ SCREW WAS UNABLE TO DISASSEMBLE. THIS REPORT IS FOR ONE (1) 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 170MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13996142 ↗

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.