NA S-1510TD-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00845384012610), received between Nov 29, 2017 and Feb 19, 2026 — classified as 104 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (85 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 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A CEREBRAL ANEURYSM CLIPPING SURGERY ON THE SKULL, WHILE DRILLING HOLES IN THE BONE AFTER A CRANIOTOMY, (1) DRILL BIT DEVICE WAS BENT AND (1) DRILL BIT DEVICE BROKE. A SPARE PRODUCT WAS USED AND THE OPERATION WAS COMPLETED WITHOUT INCIDENT. THERE WERE NO INJURIES TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393321 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING A CEREBRAL ANEURYSM CLIPPING SURGERY ON THE SKULL, WHILE DRILLING HOLES IN THE BONE AFTER A CRANIOTOMY, (1) DRILL BIT DEVICE WAS BENT AND (1) DRILL BIT DEVICE BROKE. A SPARE PRODUCT WAS USED AND THE OPERATION WAS COMPLETED WITHOUT INCIDENT. THERE WERE NO INJURIES TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393308 ↗
• MalfunctionDec 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR PNEUMOCEPHALUS ON HEAD WHERE THE CUTTING BURS WERE USED. IN THE SURGERY, DURING A CRANIOTOMY, THREE OF THE CUTTING BURRS BROKE IN SUCCESSION. THE BREAKAGE OCCURRED WHILE THEY WERE BEING USED ON A PATIENT'S BONE FRAGMENT THAT HAD BEEN REMOVED DURING THE CRANIOTOMY. THE OPERATION WAS EXTENDED BY APPROXIMATELY 10 MINUTES, BUT THE FOURTH NEW TWIST DRILL CUTTING BURR WAS OPENED AND USED BEFORE THE OPERATION WAS COMPLETED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 3 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883377 ↗
• MalfunctionDec 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR PNEUMOCEPHALUS ON HEAD WHERE THE CUTTING BURS WERE USED. IN THE SURGERY, DURING A CRANIOTOMY, THREE OF THE CUTTING BURRS BROKE IN SUCCESSION. THE BREAKAGE OCCURRED WHILE THEY WERE BEING USED ON A PATIENT'S BONE FRAGMENT THAT HAD BEEN REMOVED DURING THE CRANIOTOMY. THE OPERATION WAS EXTENDED BY APPROXIMATELY 10 MINUTES, BUT THE FOURTH NEW TWIST DRILL CUTTING BURR WAS OPENED AND USED BEFORE THE OPERATION WAS COMPLETED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883372 ↗
• MalfunctionDec 23, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR PNEUMOCEPHALUS ON HEAD WHERE THE CUTTING BURS WERE USED. IN THE SURGERY, DURING A CRANIOTOMY, THREE OF THE CUTTING BURRS BROKE IN SUCCESSION. THE BREAKAGE OCCURRED WHILE THEY WERE BEING USED ON A PATIENT'S BONE FRAGMENT THAT HAD BEEN REMOVED DURING THE CRANIOTOMY. THE OPERATION WAS EXTENDED BY APPROXIMATELY 10 MINUTES, BUT THE FOURTH NEW TWIST DRILL CUTTING BURR WAS OPENED AND USED BEFORE THE OPERATION WAS COMPLETED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 3 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883367 ↗
• MalfunctionSep 16, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A CRANIOTOMY SURGICAL PROCEDURE OF THE SKULL, WHILE CREATING THE SUTURE HOLES FOR LIFTING THE DURA MATER, THE BURR DEVICE SUDDENLY BROKE OFF WHEN BEING USED WITH THE HANDPIECE DEVICE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. 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 23061747 ↗
• MalfunctionMay 23, 2025Material Fragmentation; Material Fragmentation

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN INTRACRANIAL TUMOR REMOVAL SURGERY ON THE HEAD, THE TWO (X2)1.55MM X 10MM TWIST DR,S DEVICES WERE BEING USED WHEN THE TIPS BROKE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077694 ↗
• MalfunctionMay 23, 2025Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN INTRACRANIAL TUMOR REMOVAL SURGERY ON THE HEAD, THE TWO (X2)1.55MM X 10MM TWIST DR,S DEVICES WERE BEING USED WHEN THE TIPS BROKE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077692 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A INTRACRANIAL TUMOR REMOVAL SURGERY ON THE HEAD, IT WAS OBSERVED THAT THE TWO (X2) CUTTER DEVICES TIPS WERE BROKEN. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034378 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN INTRACRANIAL TUMOR REMOVAL SURGERY ON THE HEAD, IT WAS OBSERVED THAT THE TWO (X2) CUTTER DEVICES TIPS WERE BROKEN. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034377 ↗
• MalfunctionFeb 18, 2025Material Fragmentation; Material Fragmentation

  REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING SURGERY FOR EVACUATION OF INTRACEREBRAL HEMATOMA FOR BONE FLAP, WHEN THE SURGEON REMOVED THE BONE FLAP AND WAS DRILLING ON THE WORKBENCH, IT WAS OBSERVED THAT THE 1.55MM X 10MM TWIST DR,S DEVICE WAS BROKEN. ANOTHER NEW SAME DEVICE WAS USED, BUT IT ALSO OBSERVED TO BE BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398079 ↗
• MalfunctionFeb 18, 2025Material Fragmentation; Material Fragmentation

  REPORT 2 OF 2 FOR(B)(4). IT WAS REPORTED THAT DURING SURGERY FOR EVACUATION OF INTRACEREBRAL HEMATOMA FOR BONE FLAP, WHEN THE SURGEON REMOVED THE BONE FLAP AND WAS DRILLING ON THE WORKBENCH, IT WAS OBSERVED THAT THE 1.55MM X 10MM TWIST DR,S DEVICE WAS BROKEN. ANOTHER NEW SAME DEVICE WAS USED, BUT IT ALSO OBSERVED TO BE BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392728 ↗
• MalfunctionNov 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM JAPAN THAT DURING A SURGICAL PROCEDURE FOR AN INTRACRANIAL TUMOR RESECTION ON HEAD THE TIP BROKE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 20614535 ↗
• MalfunctionSep 10, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 2 FOR :(B)(4). IT WAS REPORTED FROM JAPAN THAT DURING A PROCEDURE FOR TRAUMATIC CLOSED ACUTE SUBDURAL HEMATOMA ON BONES OF CRANIUM, A BURR DEVICE BROKE OFF WHEN DRILLING A BONE VALVE WHILE IN USED WITH AN ATTACHMENT DEVICE AND A MOTOR DEVICE. THEY CHANGED TO ANOTHER BURR DEVICE BUT THE SAME ISSUE OCCURRED. THE BROKEN TIP OF THE FIRST PRODUCT WAS LOST IN THE FIELD, BUT A POSTOPERATIVE CT SCAN CONFIRMED THAT IT WAS NOT RETAINED IN THE PATIENT'S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. 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 20182573 ↗
• MalfunctionSep 10, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED FROM JAPAN THAT DURING A PROCEDURE FOR TRAUMATIC CLOSED ACUTE SUBDURAL HEMATOMA ON BONES OF CRANIUM, A BURR DEVICE BROKE OFF WHEN DRILLING A BONE VALVE WHILE IN USED WITH AN ATTACHMENT DEVICE AND A MOTOR DEVICE. THEY CHANGED TO ANOTHER BURR DEVICE BUT THE SAME ISSUE OCCURRED. THE BROKEN TIP OF THE FIRST PRODUCT WAS LOST IN THE FIELD, BUT A POSTOPERATIVE CT SCAN CONFIRMED THAT IT WAS NOT RETAINED IN THE PATIENT'S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. 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 20182570 ↗
• MalfunctionAug 12, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SKULL, IT WAS DISCOVERED THAT TWO CUTTING DEVICES BROKE CONSECUTIVELY. IT WAS REPORTED THAT THERE WERE NO PIECES IN THE PATIENT. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE PROCEDURE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 19960419 ↗
• MalfunctionAug 12, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 1 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SKULL, IT WAS DISCOVERED THAT TWO CUTTING DEVICES BROKE CONSECUTIVELY. IT WAS REPORTED THAT THERE WERE NO PIECES IN THE PATIENT. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE PROCEDURE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. 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 19960414 ↗
• MalfunctionAug 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE END ON THE DRILL BIT DEVICE BROKE OFF NEATLY. THERE WERE NO REPORTS OF DELAYS IN THE SURGICAL PROCEDURE NOR IF AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS 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 19943209 ↗
• MalfunctionAug 8, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE END ON THE DRILL BIT DEVICE BROKE OFF NEATLY. THERE WERE NO REPORTS OF DELAYS IN THE SURGICAL PROCEDURE NOR IF AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS 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 19942122 ↗
• MalfunctionJun 19, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, IT WAS OBSERVED THAT THE DRILL BIT DEVICE BROKEN WHILE DRILLING THE BONE FLAP. THIS HAPPENED TWO MORE TIMES. ACCORDING TO THE REPORT, ALTHOUGH THE DRILL BIT WAS APPLIED PERPENDICULAR TO THE BONE, ALL THREE DRILL BIT DEVICES WERE BROKEN DURING DRILLING. THE X-RAY SHOWED THAT THERE WERE NO BROKEN PIECES IN THE PATIENT. 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 19568485 ↗
• MalfunctionJun 19, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, IT WAS OBSERVED THAT THE DRILL BIT DEVICE BROKEN WHILE DRILLING THE BONE FLAP. THIS HAPPENED TWO MORE TIMES. ACCORDING TO THE REPORT, ALTHOUGH THE DRILL BIT WAS APPLIED PERPENDICULAR TO THE BONE, ALL THREE DRILL BIT DEVICES WERE BROKEN DURING DRILLING. THE X-RAY SHOWED THAT THERE WERE NO BROKEN PIECES IN THE PATIENT. 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 19568483 ↗
• MalfunctionJun 19, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, IT WAS OBSERVED THAT THE DRILL BIT DEVICE BROKEN WHILE DRILLING THE BONE FLAP. THIS HAPPENED TWO MORE TIMES. ACCORDING TO THE REPORT, ALTHOUGH THE DRILL BIT WAS APPLIED PERPENDICULAR TO THE BONE, ALL THREE DRILL BIT DEVICES WERE BROKEN DURING DRILLING. THE X-RAY SHOWED THAT THERE WERE NO BROKEN PIECES IN THE PATIENT. 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 19568482 ↗
• MalfunctionMay 8, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 1 OF 2 OF THE SAME EVENTS: IT WAS REPORTED FROM JAPAN THAT DURING A BRAIN TUMOR REMOVAL SURGERY, IT WAS DISCOVERED THAT TWO DRILL BIT DEVICES BROKE IN SUCCESSION WHILE BEING USED WITH AN ATTACHMENT DEVICE, DESPITE BEING OPERATED AS INTENDED. THE SURGICAL PROCEDURE PROCEEDED WITHOUT ANY DELAYS AND WAS SUCCESSFULLY COMPLETED. IT WAS NOT REPORTED IF SPARE DEVICES WERE AVAILABLE FOR USE. THE SURGEON WAS WONDERING IF THE MATERIAL OF THE DRILL BITS HAD BEEN CHANGED. 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 19268826 ↗
• MalfunctionMay 8, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 2 OF THE SAME EVENTS: IT WAS REPORTED FROM JAPAN THAT DURING A BRAIN TUMOR REMOVAL SURGERY, IT WAS DISCOVERED THAT TWO DRILL BIT DEVICES BROKE IN SUCCESSION WHILE BEING USED WITH AN ATTACHMENT DEVICE, DESPITE BEING OPERATED AS INTENDED. THE SURGICAL PROCEDURE PROCEEDED WITHOUT ANY DELAYS AND WAS SUCCESSFULLY COMPLETED. IT WAS NOT REPORTED IF SPARE DEVICES WERE AVAILABLE FOR USE. THE SURGEON WAS WONDERING IF THE MATERIAL OF THE DRILL BITS HAD BEEN CHANGED. 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 19268811 ↗
• MalfunctionMar 18, 2024Material Fragmentation; Material Fragmentation

  THIS IS REPORT 1 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT DURING TENTING, TWO BURR DEVICES BROKE IN A ROW. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR 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. 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 18921112 ↗

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-2284-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
• Z-2287-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-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-2280-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-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.
• 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-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-2296-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-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-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-2286-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.

…and 24 more.