NA S-5AC-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845384013327), received between Feb 4, 2021 and Jun 14, 2024 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE HEALTH AUTHORITY IN CHINA THAT DURING A CRANIOTOMY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT SUFFERED A CUTTING INJURY WHILE THE CUTTING BUR DEVICE WAS BEING USED, RESULTING IN PAIN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. PATIENT INVOLVEMENT AND INJURY WERE REPORTED. IT IS UNKNOWN WHETHER MEDICAL INTERVENTION WAS ADMINISTERED TO THE PATIENT OR IF PROLONGED HOSPITALIZATION WAS NECESSARY AS A CONSEQUENCE OF THIS EVENT. THERE WAS NO ALLEGED MALFUNCTION AGAINST THE DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain; Unspecified Tissue Injury

  MAUDE report 19538873 ↗
• MalfunctionJan 4, 2022Separation Problem; 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 OBSERVED THAT THE CUTTING TOOL WAS RECEIVED INSIDE THE ATTACHMENT DEVICE AND WAS REMOVED FOR ASSESSMENT. IT WAS OBSERVED THAT THE SHAFT SHOWED SIGNS OF CORROSION AND THE BURR HEAD SHOWED SIGNS OF REGULAR WEAR-WOULD NOT CUT/DULL. IT WAS NOTED IN THE SERVICE ORDER THAT THE BURR WAS STUCK IN THE ATTACHMENT DEVICE AND WOULD NOT DETACH FROM THE HANDPIECE DEVICE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13157933 ↗
• MalfunctionFeb 4, 2021Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE SHOWED HEAVY SIGNS OF WEAR, WAS STUCK IN THE ATTACHMENT DEVICE AND WAS DAMAGED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS STUCK IN THE ATTACHMENT AND MOTOR DEVICE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11282153 ↗

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-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-2281-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-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-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-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-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-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-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-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-2303-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including spine and cranium.

…and 24 more.