NA 494.784Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982236678), received between Sep 17, 2025 and Sep 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K040701, K082650, K122455, K161417, K952296); 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.

• MalfunctionSep 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN EXTERNAL SKELETAL FIXATION FOR A DISLOCATION FRACTURE OF THE ANKLE JOINT. WHEN THE SELDRILL WAS INSERTED VIA THE DRILL SLEEVE, THE THREADED PART OF THE SELDRILL GOT STUCK/JAMMED INSIDE THE DRILL SLEEVE JUST AFTER IT WENT THROUGH THE DRILL SLEEVE. THEREFORE, ANOTHER SELDRILL AND A SPARE DRILL SLEEVE WITH THE SAME PRODUCT CODE WERE USED IN THE SURGERY. THE JAMMED SELDRILL AND DRILL SLEEVE WERE MANAGED TO BE SEPARATED AFTER SURGERY, AND IT WAS FOUND THAT THE SHAFT OF THE SELDRILL WAS CLEARLY THICKER THAN THE DRILL SLEEVE IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES¿ DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073419 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040701, K082650, K122455, K161417, K952296. One submission often covers many models, so check the product and lot details in each record.

• Z-0043-2018 · Sep 18, 2017 · Terminated
  MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction
• 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.