NA 494.784SHARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982236692), received between Oct 10, 2023 and Mar 18, 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 (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 18, 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 18, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY WERE DOING EXTRA-LARGE EXTERNAL FIXATOR CASE WITH HA COAT UPON INSERTION HA COAT THROUGH THE SLEEVE THEY GOT CUT INSIDE. THE PATIENT WAS NOT AFFECTED, AND SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1)5.0 TI SELF-DRL SCHZ SCR 150/HA COAT-S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924616 ↗
• MalfunctionOct 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023. THE PATIENT UNDERWENT A TEMPORARY EXTERNAL FIXATION FOR AN ANKLE FRACTURE. WHILE DRILLING THE TIBIAL USING THE SELDRILL WITH THE SLEEVE, THE SELDRILL STOPPED ADVANCING. SINCE THE INSERTION DEPTH WAS SHALLOW, THE SELDRILL AND SLEEVE WERE ABLE TO BE REMOVED, AND THE SURGEON CONTINUED THE OPERATION WITHOUT USING A SLEEVE. THE SELDRILL AND SLEEVE GOT STUCK AND COULD NOT BE DETACHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE 5.0MM TI SELF-DRILLING SCHANZ SCREW 150MM/HA COATING-STERILE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17903958 ↗

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.