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CANNU-FLEX 014394Recalls & reported problems

Smith & Nephew, Inc. · CANNU-FLEX GDE WIRES .045X12 · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010374677), received between May 4, 2023 and May 4, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

  • Detachment of Device or Device Component1

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT, ON (B)(6) 2022, A PATIENT UNDERWENT A LEFT KNEE ACL, ALLOGRAFT WITH POSTEROLATERAL CORNER RECONSTRUCTION AND ANTEROLATERAL LIGAMENT RECONSTRUCTION. DURING THE PROCEDURE, A NITINOL WIRE WAS USED TO PLACE A SCREW. A KNEE X-RAY WAS OBTAINED AND IDENTIFIED A 3CM RADIOPAQUE LINEAR METALLIC STRUCTURE PROJECTING OVER THE POSTERIOR SOFT TISSUES OF THE KNEE. THE OBJECT, RETRIEVED AT AN UNSPECIFIED DATE, WAS A PIECE OF A NITINOL WIRE RETAINED IN THE PATIENT'S POSTERIOR KNEE. THE PATIENT STATUS IS UNKNOWN.

    Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

    MAUDE report 16872995 ↗

Other PASSER devices

All PASSER devices →

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