NA S-1R-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00845384012627), received between Jun 14, 2021 and May 5, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CRANIOTOMY SURGICAL PROCEDURE FOR BRAIN TUMOR REMOVAL USING A CRANIAL BURR DEVICE, AFTER CLOSING THE SKULL, IT WAS OBSERVED THAT THE TIP OF THE BURR DEVICE USED FOR TENTING WAS BROKEN. IT WAS REPORTED THAT THE SKULL WAS REOPENED, AND THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT WAS NOTED THAT THE FRAGMENT REMAINED IN THE BONE, DID NOT COME IN CONTACT WITH THE BLADE PROTECTING THE DURA MATER, AND THE CUTTING HAD NOT BEEN MADE AT AN ANGLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 120-MINUTE SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21960099 ↗
• MalfunctionOct 28, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE WHILE TENTING. 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 20546738 ↗
• MalfunctionAug 13, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE DURING SURGERY. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 19974636 ↗
• MalfunctionMay 14, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM JAPAN THAT DURING A BRAIN ANEURYSM CLIPPING SURGICAL PROCEDURE FOR A BRAIN TUMOR REMOVAL IN THE RIGHT TEMPORAL BONE VALVE, IT WAS OBSERVED THAT THE DRILL BIT BROKE OFF WHILE CREATING THE FIRST TENTING HOLE. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A MOTOR DEVICE AND ATTACHMENT DEVICE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 19310732 ↗
• MalfunctionApr 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM TAIWAN THAT THE MOTOR DEVICE WAS CRUSHED. 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 A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715729 ↗
• MalfunctionAug 10, 2022Material Fragmentation; Device Markings/Labelling Problem; Material Fragmentation; Device Markings/Labelling Problem

  IT WAS REPORTED FROM JAPAN THAT DURING A CRANIOTOMY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE TIP OF THE CUTTER DEVICE BROKE OFF WHILE IN USE WITH AN ATTACHMENT DEVICE AND A MOTOR DEVICE WHEN THE SURGEON WAS MAKING A BURR HOLE ON THE SEVERED PART OF THE REMOVED SKULL. IT WAS REPORTED THAT THERE WAS AN UNKNOWN DELAY TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15197526 ↗
• MalfunctionApr 11, 2022Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING A CRANIOTOMY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT ABOUT 10MM OF THE TIP OF TWO CUTTER DEVICES WERE BROKEN OFF WHEN A HOLE WAS MADE IN THE REMOVED SKULL. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14070821 ↗
• MalfunctionApr 11, 2022Material Fragmentation; Material Fragmentation

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING A CRANIOTOMY SURGICAL PROCEDURE, IT WAS DISCOVERED THAT ABOUT 10MM OF THE TIP OF TWO CUTTER DEVICES WERE BROKEN OFF WHEN A HOLE WAS MADE IN THE REMOVED SKULL. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2022. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14070815 ↗
• MalfunctionSep 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE TIP BROKE OFF WHILE THE SURGEON WAS DRILLING THE SEPARATED CRANIAL BONE AT THE NON-SURGICAL FIELD. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITHOUT DELAYS. 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 12452686 ↗
• MalfunctionJun 14, 2021Material Fragmentation; Dull, Blunt; Separation Problem; Material Fragmentation; Dull, Blunt; Separation Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BUR DEVICE FAILED VISUAL INSPECTION. IT WAS DETERMINED THAT THE BUR DEVICE WAS STUCK INSIDE THE ATTACHMENT DEVICE BUT COULD BE RELEASED. IT WAS FURTHER DETERMINED THAT THE BUR DEVICE SHOWED HEAVY SIGNS OF USAGE MOSTLY ALONG THE SHAFT, DISCOLORATION WAS VERIFIED AND THE CUTTING EDGE WAS USED UP. IT WAS OBSERVED THAT THE BACK END OF THE BUR DEVICE USED FOR LOCKING INSIDE THE HANDPIECE WAS MISSING. IT WAS NOTED IN THE SERVICE ORDER THAT THE CUTTING BURR DEVICE WAS UNABLE TO BE REMOVED FROM THE ATTACHMENT DEVICE AND THE ATTACHMENT DEVICE HAD AN OVERHEATING ISSUE. 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 11995923 ↗

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-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-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; For cutting and 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-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-2300-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine and cranium.
• Z-2289-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-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-2299-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 7MM Fluted Acorn; REF M-7AC-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-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-2294-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-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.