NA 294.68SHARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982181664), received between Jun 19, 2019 and Jun 19, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OF MAXFRAME TO REPLACE BROKEN SCHANZ PIN. THE PIN WAS BROKEN AT THE THREAD SHAFT JUNCTION. THE SCHANZ PIN WAS PARTIALLY REMOVED. THE DEEP BURIED PART OF THE BROKEN PIN WAS NOT ATTEMPTED TO BE REMOVED AND REMAINS IN THE PATIENT. THE SURGEON ELECTED NOT TO GO AFTER THE BROKEN SHORT SEGMENT OF THE PIN THAT REMAINS IN THE BONE. SEVERAL NEW SCHANZ PIN WERE PUT IN TO REPLACE THE BROKEN ONE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN MAXFRAME (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 6.0MM SCHANZ SCREW SPADE POINT 190MM/HA COATING-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8712116 ↗

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.