NA M-8NS-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845384012535), received between May 7, 2020 and Sep 15, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2021Dull, Blunt; Separation Problem; Dull, Blunt; Separation Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BURR DEVICE FAILED VISUAL INSPECTION. IT WAS FURTHER DETERMINED THAT THE BURR DEVICE COULD BE REMOVED FROM THE ATTACHMENT DEVICE AND THE DESCRIBED FAILURE BY THE CUSTOMER THAT THE BURR DEVICE WAS UNABLE TO DETACH WAS NOT CONFIRMED. IT WAS OBSERVED THAT THE BURR DEVICE BLADES BARELY SHOWED SIGNS OF WEAR BUT FOREIGN SUBSTANCE ON THE CUTTING HEAD AND CORROSION ON THE SHAFT COULD BE DETECTED. IT WAS NOTED THAT ANSPACH BURRS ARE SINGLE USE PRODUCTS. IT WAS FURTHER DETERMINED THAT THE BURR DEVICE WAS JAMMED INSIDE THE ATTACHMENT DEVICE AND THEN REPROCESSED ALONG WITH THE ATTACHMENT DEVICE. IT WAS NOTED IN THE SERVICE ORDER THAT BURR DEVICE WAS UNABLE TO DETACH. IT WAS DETERMINED THAT THE MOST PROBABLE CAUSE FOR THE FOUND DEFECT WAS WEAR OVER TIME AND CORROSION ON THE SHAFT AND REMAINING RESIDUES COULD BE LINKED TO IMPROPER REPROCESSING. 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 ME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474001 ↗
• MalfunctionAug 11, 2021Material Deformation; Separation Problem; Material Deformation; Separation Problem

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE WAS STUCK IN THE ATTACHMENT AND WAS NOT POSSIBLE TO REMOVE FROM THE ATTACHMENT DEVICE. IT WAS ALSO REPORTED DETERMINED THAT THE DEVICE WAS HEAVILY WORN AND CORRODED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS UNABLE TO DETACH FROM THE ATTACHMENT. 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 BECOME AVAILABLE, AN ADDITIONAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309883 ↗
• MalfunctionOct 13, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUTTER DEVICE WAS NOT ABLE TO BE DETACHED FROM THE ATTACHMENT DEVICE AND THE ATTACHMENT DEVICE HAD BEARING DAMAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE COULD NOT BE REMOVED FROM THE ATTACHMENT DEVICE, WAS FOUND TO BE BROKEN WHEN REMOVED FROM THE ATTACHMENT, THERE WERE SIGNS OF CORROSION IN THE BEARINGS AND CUTTER SHAFT, AND THE CUTTER BLADES SHOWED SIGNS OF HEAVY USE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10670098 ↗
• MalfunctionMay 7, 2020Break; Break

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE WAS WORN AND STUCK IN THE ATTACHMENT DEVICE. IT WAS NOTED THAT A SMALL AMOUNT OF DEBRIS WAS IDENTIFIED AT THE COUPLING PART. IT WAS NOTED THAT THERE WERE SOME MARKS FOUND DUE TO THE WORN ATTACHMENT DEVICE. THE CUTTER DEVICE SHOWED SIGNS OF REGULAR USAGE. IT WAS NOTED IN THE SERVICE ORDER THAT THE ATTACHMENT DEVICE WAS STUCK TO A MOTOR DEVICE WITH AN UNKNOWN BURR DEVICE STUCK IN IT THAT COULD NOT BE RELEASED. 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 BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10033757 ↗

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-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; 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-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-2284-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
• Z-2295-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium.
• Z-2291-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2298-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.
• Z-2312-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 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.
• Z-2286-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
• Z-2305-2015 · Apr 13, 2015 · Terminated
  ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.
• Z-2288-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.
• Z-2290-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Ball; 9MM REF L-9B-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.

…and 24 more.