NA 352.055Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982194169), received between Aug 14, 2019 and Sep 25, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Break; Entrapment of Device; Break; Entrapment of Device

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17810944 ↗
• MalfunctionFeb 1, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE REDUCTION HEAD-ANGLED BROKE OFF. THE SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS AND SOFT TISSUE ATTACHMENT J-SHAPE F/REDUCTION FORCEPS BALL AND PLASTIC PIECE BROKE. THE REDUCTION TOOL/CURVED WITH QUICK COUPLING WOULDN¿T ATTACH TO T HANDLE QUICK COUPLING (QC); IT SEEMED TO BE CROSS THREADED. TWO (2) 1.8MM COAXIAL DRILL GUIDES CROSS THREADED. TWO (2) RETRACTOR FOR SCIATIC NERVE WERE BENT. AND THE TIP OF THE REAMING ROD PUSH ROD BROKE OFF. ALL EQUIPMENT WAS USED DURING SURGERY AND HAD MALFUNCTIONED. SURGERY WAS DELAYED FIVE TO 10 (5-10) MINUTES. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A 7.0MM REDUCTION HEAD-ANGLED. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11261928 ↗
• InjuryAug 14, 2019Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM PERU REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2019, THE SURGEON INTRODUCED THE REDUCTION GUIDE BEFORE THE FLEXIBLE GUIDE, AND THE TIP OF THE REDUCTION GUIDE REMAINED IN THE PATIENT'S MEDULLARY CANAL AND WAS NOT REMOVED. SURGERY WAS DELAYED 15 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8892962 ↗