NA 294.785Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982182166), received between Nov 17, 2020 and Sep 28, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SLEEVE IS BENT AND WEDGED SHANZ PIN. IT IS UNABLE TO SPECTATE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.0 SELF-DRILLING SCHANZ SCR 60 THRD/175. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836509 ↗
• MalfunctionSep 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE SLEEVE IS BENT AND WEDGED SHANZ PIN. IT IS UNABLE TO SPECTATE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 5.0 SELF-DRILLING SCHANZ SCR 60 THRD/175 THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836226 ↗
• InjuryNov 17, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF EXTERNAL FIXATOR AND SCHANZ SCREW. A SELF-DRILLING SCHANZ SCREW BROKE AFTER MULTIPLE WEEKS OF BEING USED AS AN EXTERNAL FIXATOR. HE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE FRAGMENTS GENERATED ON THE BROKEN DEVICE BUT WAS ABLE TO REMOVE ALL SELF-DRILLING SCHANZ SCREW BY HAND IN CLINIC WITHOUT ANESTHESIA DUE TO PATIENT'S NEUROPATHY. THE PATIENT IS CURRENTLY IN A BELOW THE KNEE CAST UNTIL DEFINITIVE SURGICAL CORRECTION. CONCOMITANT DEVICES REPORTED: SELF-DRILLING SCHANZ SCREW 80MM THRD/250MM (PRODUCT CODE: 294.788, LOT NUMBER: 61P2452, QUANTITY: 2). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.0MM SELF-DRILLING SCHANZ SCREW 60MM THRD/175MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10852850 ↗
• InjuryNov 17, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF EXTERNAL FIXATOR AND SCHANZ SCREW. A SELF-DRILLING SCHANZ SCREW BROKE AFTER MULTIPLE WEEKS OF BEING USED AS AN EXTERNAL FIXATOR. HE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE FRAGMENTS GENERATED ON THE BROKEN DEVICE BUT WAS ABLE TO REMOVE ALL SELF-DRILLING SCHANZ SCREW BY HAND IN CLINIC WITHOUT ANESTHESIA DUE TO PATIENT'S NEUROPATHY. THE PATIENT IS CURRENTLY IN A BELOW THE KNEE CAST UNTIL DEFINITIVE SURGICAL CORRECTION. CONCOMITANT DEVICES REPORTED: SELF-DRILLING SCHANZ SCREW 80MM THRD/250MM (PRODUCT CODE: 294.788, LOT NUMBER: 61P2452, QUANTITY: 2). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.0MM SELF-DRILLING SCHANZ SCREW 60MM THRD/175MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10852838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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.