NA M-8N-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845384013150), received between Dec 4, 2019 and Sep 9, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

39 other recalls cover devices cleared under the same FDA submission (K113476); they may or may not involve this specific model.

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.

• MalfunctionSep 9, 2021Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE COMPLETE DRILL BIT DEVICE WAS STUCK IN THE ATTACHMENT DEVICE. IT WAS DETERMINED THAT IT WAS NOT POSSIBLE TO REMOVE THE DRILL BIT DEVICE FROM THE ATTACHMENT DEVICE. IT WAS OBSERVED THAT BASED ON THE PHOTOGRAPHS PROVIDED THE DRILL BIT WAS CORRODED AND DAMAGED. IT WAS NOTED IN THE SERVICE ORDER THAT THE BURR DEVICE WAS UNABLE TO DETACH FROM THE ATTACHMENT DEVICE. IT WAS DETERMINED THAT THE CAUSE FOR THE STUCK BIT WAS NOT RELATED TO ANY PROBLEM WITH THE DRILL BIT DEVICE ITSELF. IT WAS FURTHER DETERMINED THAT THE ROOT CAUSE FOR THE OVERALL CONDITION OF THE DRILL BIT DEVICE WAS NORMAL WEAR AND THE CORROSION WAS LINKED TO IMPROPER HANDLING BY THE CUSTOMER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446805 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 4 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL DISCECTOMY SURGICAL PROCEDURE (UNDER MICROSCOPE), IT WAS OBSERVED THAT THE MOTOR DEVICE, WHILE BEING USED WITH A HANDSET DEVICE, BURR DEVICE AND AN ATTACHMENT DEVICE, WAS CONTINUALLY OVERHEATING. IT WAS REPORTED THAT DUE TO LIMITED DRILL AVAILABILITY AT THE TIME, THE USER PERSEVERED REDUCING THE LENGTH OF THE DUTY CYCLE (TIME OF CONTINUED USE) TO ALLOW THE DRILL TO COOL IN BETWEEN USES. IT WAS FURTHER REPORTED THAT DURING BONE SMOOTHING AT THE POSTERIOR AND CERVICAL END PLATE AND NEAR THE SPINAL CORD, THE USER OBSERVED A COMBINATION OF DARK FLUID AND WHAT APPEARED TO BE DARKER METAL FILINGS WHICH SPRAYED INTO THE DISC SPACE. IT WAS AT THIS POINT THAT THE USER STOPPED DRILLING AND PROCEEDED TO LIBERALLY IRRIGATE THE AREA IN ORDER TO COOL THE LIQUID THAT MAY HAVE BEEN HOT IN ORDER TO PREVENT DAMAGE TO THE CORD. IT WAS REPORTED THAT AFTER SEVERAL MINUTES THE USER AND ASSISTANT WERE ABLE TO SUCK UP THE FLUID ALONG WITH ANY FOREIGN DEBRIS. AFTER CAREFUL INSPECTION OF THE SURGICAL SITE, THE SURGEON CONTINUED THE DISCECTOMY AND FUSION WITHOUT THE USE OF THE DRILL. IT WAS REPORTED THAT THERE WAS A 15

  Patient problems: Foreign Body In Patient

  MAUDE report 9412198 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113476. One submission often covers many models, so check the product and lot details in each record.

• Z-2838-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
• Z-2840-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
• Z-2309-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium.
• Z-2299-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium.
• Z-2287-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
• Z-2304-2015 · Apr 13, 2015 · Terminated
  ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.
• Z-2300-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine and cranium.
• Z-2285-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2297-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including spine and cranium.
• Z-2293-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone including spine and cranium.
• Z-2283-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2308-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.
• Z-2307-2015 · Apr 13, 2015 · Terminated
  ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.

…and 24 more.