NA 398.93Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982201980), received between Oct 16, 2018 and Dec 16, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE "SPRING" THAT APPLIES TENSION OF THE BONE SPREADER 7MM BEAK WIDTH WAS BROKEN. IT IS UNKNOWN IF THERE WAS PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR (1) BONE SPREADER 7MM BEAK WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018477 ↗
• MalfunctionAug 16, 2019Break; Break

  IT WAS REPORTED ON JULY 19, 2019, THE UNIVERSAL CHUCK WITH T-HANDLE WAS BENT AND THE TIP OF THE BONE SPREADER BEAK BROKE OFF DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) BONE SPREADER 7 MM BEAK WIDTH THIS REPORT IS FOR 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8902786 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION ON AN UNKNOWN DATE, WHILE CLEANING IN STERILE PROCESSING DEPARTMENT (SPD), THE BONE SPREADER CAME OUT BROKEN. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) BONE SPREADER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8388483 ↗
• MalfunctionOct 16, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT THE STOP NUT FOR THE SPEED LOCK IN A BONE SPREADER WAS OBSERVED MISSING DURING CLEANING ON AN UNKNOWN DATE. THE BONE SPREADER WAS TAKEN APART AND THE STOP NUT GOT LOST AT THE TIME. THERE WAS NO PATIENT AND PROCEDURAL INVOLVEMENT REPORTED. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS COMPLAINT IS FOR ONE (1) BONE SPREADER 7 MM BEAK WIDTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7969498 ↗