NA M-5DC-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845384013037), received between Sep 16, 2021 and Sep 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE WOULD NOT CUT/DULL. THE CUTTER WAS REMOVED FROM THE ATTACHMENT DEVICE AND IT WAS DETERMINED THAT THE CUTTING HEAD SHOWED SIGNS OF WEAR. IT WAS FURTHER OBSERVED THAT THE SHAFT HAD CORROSION/RUSTING/PITTING AND THE DEVICE FAILED VISUAL INSPECTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE CUTTER DEVICE HAD AN UNDETERMINED MALFUNCTION, AND THE ATTACHMENT DEVICE DID NOT WORK ANYMORE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484613 ↗

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-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; 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-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-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-2306-2015 · Apr 13, 2015 · Terminated
  ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-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-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-2302-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-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-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-2313-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-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-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-2284-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
• Z-2282-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.

…and 24 more.