NA 494.769Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982236364), received between Oct 20, 2022 and Oct 20, 2022 — 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 (K002605, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT EXTERNAL FIXATION FOR A DISTAL RADIUS FRACTURE WITH THE PRODUCTS IN QUESTION. WITH THE RODS AND CLAMPS OF A Z FRAME EXTERNAL FIXATOR, THE SURGEON ATTEMPTED TO DRILL A 2.5/4.0 SELDRILL USING A 4.0 MM THREADED DRILL SLEEVE, BUT THE SELDRILL JAMMED IN THE SLEEVE AND COULD NOT BE INSERTED INTO THE BONE. HE CHECKED IF HE HAD INSERTED THE SELDRILL AT AN ANGLE, BUT IT STILL DID NOT PASS. HE TRIED TO PUNCTURE WITH OTHER SELDRILLS, BUT ALL OF THEM EXPERIENCED INTERFERENCE IN THE SLEEVE. THE SURGEON WAS ABLE TO COMPLETE THIS STEP USING ANOTHER PRODUCT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF UNDER 30 MINUTES. AFTER CLEANING THE DRILL SLEEVE, IT IS FOUND THAT THE INSIDE OF THE SLEEVE THERE WAS A BURR-LIKE OBJECT HAD FORMED AROUND THE CIRCUMFERENCE OF THE SLEEVE, CAUSING THE 4.0 CELL DRILL TO POKE INTO IT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.0MM/2.5MM TI SELF-DRILLING SCHANZ SCREW 20MM THRD/80MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639328 ↗
• MalfunctionOct 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT EXTERNAL FIXATION FOR A DISTAL RADIUS FRACTURE WITH THE PRODUCTS IN QUESTION. WITH THE RODS AND CLAMPS OF A Z FRAME EXTERNAL FIXATOR, THE SURGEON ATTEMPTED TO DRILL A 2.5/4.0 SELDRILL USING A 4.0 MM THREADED DRILL SLEEVE, BUT THE SELDRILL JAMMED IN THE SLEEVE AND COULD NOT BE INSERTED INTO THE BONE. HE CHECKED IF HE HAD INSERTED THE SELDRILL AT AN ANGLE, BUT IT STILL DID NOT PASS. HE TRIED TO PUNCTURE WITH OTHER SELDRILLS, BUT ALL OF THEM EXPERIENCED INTERFERENCE IN THE SLEEVE. THE SURGEON WAS ABLE TO COMPLETE THIS STEP USING ANOTHER PRODUCT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF UNDER 30 MINUTES. AFTER CLEANING THE DRILL SLEEVE, IT IS FOUND THAT THE INSIDE OF THE SLEEVE THERE WAS A BURR-LIKE OBJECT HAD FORMED AROUND THE CIRCUMFERENCE OF THE SLEEVE, CAUSING THE 4.0 CELL DRILL TO POKE INTO IT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.0MM/2.5MM TI SELF-DRILLING SCHANZ SCREW 20MM THRD/80MM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639322 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002605, 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.