BoneScalpel MXB-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841626101104), received between Nov 30, 2017 and Oct 11, 2018 — classified as 4 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. 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.

• MalfunctionOct 11, 2018Fracture; Fracture

  CUSTOMER STATED PROBLEM, "BLADE BROKE DURING USE AND CRACKED INTO 3 PIECES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7958730 ↗
• MalfunctionAug 8, 2018Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER REPORTED TO FDA ON UF REPORT# (B)(4), "DURING USE OF THE ULTRASONIC BONE SCALPEL DURING A NEUROLOGICAL SURGERY CASE, A SECTION OF THE 10MM BLUNT BLADE BROKE OFF NEAR THE DISTAL END OF THE BLADE AND SEPARATED FROM THE BLADE. THE WOUND, SPONGES, COLLECTED BONE WERE SEARCHED WELL AS X-RAY IMAGES TO RETRIEVE BROKEN SECTION OF THE BLADE. INSTRUMENT FRAGMENT WAS NOT LOCATED AND SURGEON DECIDED TO CLOSE WOUND. CASE COMPLETED WITH NO ADDITIONAL COMPLICATIONS. BROKEN BONE SCALPEL AND ACCESSORIES WERE SEQUESTERED AND DELIVERED TO BIOMEDICAL FOR REPORTING AND DELIVERY TO MANUFACTURER."

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

  MAUDE report 7764175 ↗
• MalfunctionMar 1, 2018Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER STATED PROBLEM IN REPORTED MEDWATCH, "WHILE IT WAS BEING USED DURING SURGERY A PIECE OF THE BONE SCALPEL BLADE WAS NOTED TO BREAK OFF. WOUND WAS SEARCHED, ALL FRAGMENTS PRESENT. X-RAY TAKEN, READ AS NEGATIVE FOR RETAINED PIECES OF THE BONE SCALPEL. NO HARM TO PATIENT."

  Patient problems: No Information

  MAUDE report 7306466 ↗
• MalfunctionNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT IS IN RESPONSE TO MEDWATCH REPORT MW5072975 RECEIVED BY MISONIX, INC ON (B)(6) 2017 VIA US POSTAL SERVICE. MEDWATCH REPORTS THAT A MISONIX BONESCALPEL ULTRASONIC SYSTEM MXB-10 BLADE TIP BROKE DURING USE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7071346 ↗