NA P-CRN-4-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845384013785), received between May 10, 2024 and May 10, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• MalfunctionMay 10, 2024Material Fragmentation; Appropriate Device Problem Term/Code Not Available; Material Fragmentation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED FROM A HEALTH AUTHORITY IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE AFTER THIRTY FIVE MINUTES INTO THE PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE. DURING FIRST AID A DOUBLE-EDGED MILLING THE CUTTER WAS USED TO DRILL A HOLE IN THE SKULL. THE HEAD END OF THE MILLING CUTTER SUDDENLY FRACTURED AND DISINTEGRATED TO THE SECOND AID CHEST AND THEN FELL OFF. ABOUT ONE CENTIMETER WAS MISSING. THE RADIOLOGY DEPARTMENT WAS INFORMED OF ANTEROPOSTERIOR AND LATERAL RADIOGRAPHY IN THE OPERATION ROOM. THERE WAS NO FOREIGN BODY LEFT IN THE PATIENT. THE DOCTOR DECIDED TO STOP THE PROCEDURE. A SUBSEQUENT SURGERY WENT WELL. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19286155 ↗

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-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-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; 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-2310-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.
• Z-2292-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-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-2311-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-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-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-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-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-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-2301-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-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.

…and 24 more.