NA SHD-9AC-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00845384012917), received between Apr 14, 2020 and Sep 24, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM (B)(6) THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE PROXIMAL END OF THE CUTTER DEVICE SHAFT BROKE WHEN USED WITH A 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. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580143 ↗
• MalfunctionSep 20, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM (B)(6) THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE BURR DEVICE BROKE AT THE PROXIMAL END OF THE SHAFT WHILE BEING USED TOGETHER WITH THE HANDPIECE DEVICE. IT WAS REPORTED THAT THERE WERE A FEW MINUTES DELAY TO THE SURGICAL PROCEDURE, AND A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED AS INTENDED. THERE WAS NO 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 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10557954 ↗
• MalfunctionSep 15, 2020Material Fragmentation; Material Fragmentation

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT BEFORE SURGERY WHILE PREPPING, IT WAS DISCOVERED THAT TWO BURR DEVICES BROKE AT THE PROXIMAL END (THE END THAT INSERTED INTO THE HANDPIECE DEVICE). THE REPORTER STATED THAT BOTH DEVICES WERE FROM THE SAME LOT NUMBER. THE REPORTER FURTHER STATED THAT ALL THE DEVICES WERE DISCARDED. IT WAS REPORTED THAT THERE WAS A FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE AND SPARE DEVICES WERE AVAILABLE FOR USE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED AS INTENDED. THERE WAS NO 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 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10536671 ↗
• MalfunctionSep 15, 2020Material Fragmentation; Material Fragmentation

  THIS IS REPORT 1 OF 2 OF THE SAME EVENT: IT WAS REPORTED FROM (B)(6) THAT BEFORE SURGERY WHILE PREPPING, IT WAS DISCOVERED THAT TWO BURR DEVICES BROKE AT THE PROXIMAL END (THE END THAT INSERTED INTO THE HANDPIECE DEVICE). THE REPORTER STATED THAT BOTH DEVICES WERE FROM THE SAME LOT NUMBER. THE REPORTER FURTHER STATED THAT ALL THE DEVICES WERE DISCARDED. IT WAS REPORTED THAT THERE WAS A FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE AND SPARE DEVICES WERE AVAILABLE FOR USE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED AS INTENDED. THERE WAS NO 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 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10536669 ↗
• MalfunctionSep 10, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM (B)(6) THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE BURR DEVICE BROKE WHILE BEING INSERTED INTO THE ATTACHMENT DEVICE. IT WAS REPORTED THAT THERE WAS NO DELAY TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED AS INTENDED. THERE WAS NO 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 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10514991 ↗
• MalfunctionApr 14, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE BURR DEVICE BROKE BY THE SHAFT. IT WAS REPORTED THAT THE BROKEN END OF THE BURR DEVICE WAS LODGED IN THE DRILL DEVICE TEMPORARILY. IT WAS REPORTED THAT AN IDENTICAL SPARE BURR DEVICE WAS USED WITH A DIFFERENT DRILL DEVICE AND EVERYTHING WORKED FINE. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE DUE TO THE EVENT. 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 Consequences Or Impact To Patient

  MAUDE report 9958974 ↗

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-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-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-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; 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-2284-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Acorn, 7MM REF L-7AC-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-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-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-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-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-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-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-2300-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine and cranium.

…and 24 more.