BoneScalpel MXB-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841626101142), received between Nov 30, 2017 and Jan 19, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Human Factors Issue” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2018Human-Device Interface Problem; Human-Device Interface Problem

  CUSTOMER STATED EVENT: DURING A LATERAL TRANSTHORACIC RETRO-PLEURAL CORPECTOMY WITH REMOVAL OF HERNIATED DISC, THE SURGEON WAS USING THE BONE SCALPEL AND THE TIP OF THE BLADE BROKE OFF. AN X-RAY WAS PERFORMED TO ASSURE THAT THE TIP WAS NOT IN THE SURGICAL WOUND. THE X-RAY WAS REPORTED AS NEGATIVE BY THE RADIOLOGIST. IT IS BELIEVED THAT THE TIP WAS SUCTIONED INTO THE SUCTION CANISTER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Disc Impingement

  MAUDE report 7205621 ↗
• InjuryNov 30, 2017Use of Incorrect Control/Treatment Settings; Use of Device Problem; Human Factors Issue; Use of Incorrect Control/Treatment Settings; Use of Device Problem; Human Factors Issue

  THE VERBATIM REPORT FROM THE USER IS AS FOLLOWS: DETAILS : (B)(6) 2017 - PROF (B)(6) WAS PERFORMING A LAMINECTOMY OF L5-S1. AT THE END OF THE CASE WE NOTICED THE BLADE HAD BLACKENED, SUGGESTING OVERHEATING. WE HAD REDUCED THE IRRIGATION TO 30% DUE TO COMPLAINTS ABOUT TOO MUCH WATER IN THE WOUND. THE PULSE HAD BEEN RAISED TO 9. AFTER SHOWING NO ADVERSE EFFECTS POST OP FOR 2 OR 3 DAYS, THE PATIENT SHOWED SYMPTOMS CONSISTENT WITH A DURAL LEAK. THE PATIENT WAS REVISED 5 DAYS LATER ON (B)(6) 2017. PROF (B)(6) REPORTS A NECROSED SCAR ON THE DURA IN LINE WITH THE LAMINA REMOVAL. HIS STRONG BELIEF IS THAT THE BLADE HAD BURNT THE DURA AND THE NECROSED TISSUE HAS GRADUALLY GIVEN WAY, LEADING TO THE LEAK.

  Patient problems: Headache

  MAUDE report 7071144 ↗