NA 294.56Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982181572), received between Oct 31, 2018 and Oct 17, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED DURING REMOVING THE PATIENT'S EXTERNAL TUTOR FOR A CEM FEMUR INTRAMEDULLARY NAIL, THE DOCTOR REALIZED THAT TWO SCHANZ WERE BROKEN AND COULD NOT REMOVE THEM FROM THE PATIENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321989 ↗
• MalfunctionOct 17, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED DURING REMOVING THE PATIENT'S EXTERNAL TUTOR FOR A CEM FEMUR INTRAMEDULLARY NAIL, THE DOCTOR REALIZED THAT TWO SCHANZ WERE BROKEN AND COULD NOT REMOVE THEM FROM THE PATIENT. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321730 ↗
• MalfunctionSep 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON SEPTEMBER 11, 2024, TWO SLEEVES FROM THE LARGE DISTRACTOR SET WERE FOUND BY STERILE PROCESSING DEPARTMENT TO HAVE THE WING NUTS BROKE OFF INSIDE THE SLEEVES WITH THE SCHANZ PINS STILL INSIDE THE SLEEVES. THE SCHANZ PINS WERE UNABLE TO BE REMOVED. IT IS UNKNOWN WHEN THE EVENT OCCURRED. NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20320349 ↗
• MalfunctionSep 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2024, TWO SLEEVES FROM THE LARGE DISTRACTOR SET WERE FOUND BY STERILE PROCESSING DEPARTMENT TO HAVE THE WING NUTS BROKE OFF INSIDE THE SLEEVES WITH THE SCHANZ PINS STILL INSIDE THE SLEEVES. THE SCHANZ PINS WERE UNABLE TO BE REMOVED. IT IS UNKNOWN WHEN THE EVENT OCCURRED. NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20320347 ↗
• MalfunctionMar 1, 2023Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 9,2023 WHILE TIGHTENING THE WING NUT TO LOCK THE SCHANZ PIN IN PLACE, THE WING NUT BROKE INSIDE THE HOLDING SLEEVE. THE CASE PROCEEDED WITHOUT DELAY. THE DISTRACTOR ASSEMBLY WAS TAKEN APART, AND A T HANDLE CHUCK WAS USED TO REMOVE THE SCHANZ PIN AT THE END OF THE CASE. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES WAS REPORTED. THIS COMPLAIN INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 5.0 SCHANZ SCR BLUNTED TROCAR POINT 200. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462102 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR CORRECTION OF BONY OR SOFT TISSUE DEFORMITIES ON AN UNKNOWN DATE. A DEPUY SYNTHES IMPLANT WAS USED IN CONJUNCTION WITH MAXFRAME - SELF TAPPED SCHANZ SCREW. THE PATIENT EXPERIENCED POSTOPERATIVE INFECTION 6 WEEKS AFTER FRAME APPLICATION SECONDARY TO PERIPHERAL VASCULAR DISEASE. THIS LED TO A BELOW THE KNEE AMPUTATION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 200MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Impaired Healing; Nonunion/Delayed-union Bone Fracture; Unspecified Infection

  MAUDE report 16087720 ↗
• MalfunctionJan 7, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEPTH GAUGE 2.0/2.4MM DEPTH PROBE TIP SNAPPED OFF. THE SCHANTZ SCREW 5.0MM TROCAR POINT STUCK INSIDE HOLDING SLEEVE. AND THE HOLDING SLEEVE TIGHTENING KEY BROKE OFF, UNABLE TO REMOVE SCHANTZ SCREW INSIDE. NO OTHER DETAILS HAVE BEEN PROVIDED. THIS REPORT IS FOR ONE (1) 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 200MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557803 ↗
• InjuryOct 31, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT UNDERWENT REMOVAL OF A BROKEN 5.0MM SCHANZ SCREW. AT THE SAME TIME THE PATIENT ALSO WAS IMPLANTED WITH A PLATE AND SCREWS ON THE SAME DATE. THE PLATE AND SCREWS WERE SYNTHES DEVICES AND INTACT. THE PATIENT ORIGINALLY HAD AN EXTERNAL FIXATOR PERFORMED ON (B)(6). AS A MEDICAL INTERVENTION THE SURGEON REMOVED THE BROKEN SCHANZ SCREW, AND JUST LEFT THE PLATE AND SCREWS IN THE PATIENT. IT WAS UNKNOWN IF THERE WERE ANY SURGICAL DELAYS AND IF THERE WERE FRAGMENTS GENERATED FROM THE BROKEN DEVICE. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE: PLATE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1), SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) 5.0MM SCHANZ SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8026431 ↗

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.