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NA 292.727Recalls & reported problems

Synthes GmbH · 1.6MM NON-THREADED GUIDE WIRE- SPADE POINT ON ONE END 150MM · Class 1

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982180919), received between Feb 11, 2021 and Feb 11, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 reports).

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

Device problems

  • Material Deformation3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 11, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, FOUR (4) HEXAGONAL SCREWDRIVER SHAFTS WERE STRIPPED, ONE (1) ELITE IMPRESSION IMPLANT KIT WAS BROKEN, ONE (1) COMPRESSION WIRE WAS BROKEN, AND THREE (3) NON-THREADED GUIDEWIRE WERE BROKEN. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 1.6MM NON-THREADED GUIDE WIRE- SPADE POINT ON ONE END 150MM. THIS IS REPORT 5 OF 9 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11319219 ↗
  • MalfunctionFeb 11, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, FOUR (4) HEXAGONAL SCREWDRIVER SHAFTS WERE STRIPPED, ONE (1) ELITE IMPRESSION IMPLANT KIT WAS BROKEN, ONE (1) COMPRESSION WIRE WAS BROKEN, AND THREE (3) NON-THREADED GUIDEWIRE WERE BROKEN. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 1.6MM NON-THREADED GUIDE WIRE- SPADE POINT ON ONE END 150MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11319168 ↗
  • MalfunctionFeb 11, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN UNKNOWN SURGERY PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, FOUR (4) HEXAGONAL SCREWDRIVER SHAFTS WERE STRIPPED, ONE (1) ELITE IMPRESSION IMPLANT KIT WAS BROKEN, ONE (1) COMPRESSION WIRE WAS BROKEN, AND THREE (3) NON-THREADED GUIDEWIRE WERE BROKEN. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE OUTCOME IS UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 1.6MM NON-THREADED GUIDE WIRE- SPADE POINT ON ONE END 150MM. THIS IS REPORT 3 OF 9 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11319132 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.