BoneScalpel MXB-B1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841626101197), received between Dec 21, 2017 and Dec 13, 2018 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (2 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2018Material Fragmentation; Material Fragmentation

  CUSTOMER STATED PROBLEM AS "THE TIP OF A THIN BONESCALPEL BLADE BROKE WHILE WE WERE USING IT IN THE OPERATING ROOM ON (B)(6) 2018. IT WAS IN HEAVY USE AT THE TIME - THE BREAKAGE OCCURRED DURING OUR 4TH MANDIBULAR OSTEOTOMY. WE WERE ABLE TO FIND ABOUT ½ OF THE TIP IN THE WOUND, BUT COULD NOT FIND THE OTHER HALF. ON POSTOP X-RAY, WE THINK WE SEE IT AS A SMALL METALLIC FRAGMENT. WE INFORMED THE PATIENT AND WE DO NOT FEEL THERE WILL BE ANY LONG-TERM CONSEQUENCE. "

  Patient problems: Foreign Body In Patient

  MAUDE report 8161337 ↗
• MalfunctionSep 26, 2018Fracture; Fracture

  CUSTOMER STATED PROBLEM AS "BLADE CRACKED DURING SURGERY" AND CONSIDERED THIS AN ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7910236 ↗
• MalfunctionAug 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATED PROBLEM AS "TIP BROKE LOSE WHILE OPERATING."

  Patient problems: No Information

  MAUDE report 7809424 ↗
• MalfunctionAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATED PROBLEM AS "BLADE BROKE DURING SURGERY."

  Patient problems: No Information

  MAUDE report 7780574 ↗
• MalfunctionMay 24, 2018Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER STATED PROBLEM WAS "THE BLADE IS BROKEN IN 2 PIECES."

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7542832 ↗
• MalfunctionFeb 22, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  CUSTOMER STATED PROBLEM WAS "UPON PRIMING THE IRRIGATION TUBING, TIP SHOT OUT SPARKS AND BLEW OFF FORCEFULLY. THANKFULLY, NO ONE WAS INJURED OR IN THE WAY OF THE TIP EXPULSION."

  Patient problems: No Information

  MAUDE report 7290541 ↗
• MalfunctionDec 21, 2017Human-Device Interface Problem; Insufficient Device Problem Information; Human-Device Interface Problem; Insufficient Device Problem Information

  CUSTOMER STATED PROBLEM WAS THAT THE BLADE TIP BROKE DURING SURGERY.

  Patient problems: No Information

  MAUDE report 7140124 ↗