NA SHD-6R-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00845384012887), received between Jan 4, 2018 and Oct 11, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM CANADA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CUTTER DEVICE BROKEN, AND THE BROKEN PIECES WERE RETRIEVED. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 17914807 ↗
• MalfunctionSep 29, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM CANADA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE BURR DEVICE BROKE. IT WAS REPORTED THAT THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY 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 17843838 ↗
• MalfunctionDec 13, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM CANADA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CUTTER DEVICE BROKE. A SECOND, SPARE DEVICE WAS OPENED, AND THAT DEVICE BROKE AS WELL. A THIRD, SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE BROKEN PIECES OF THE DEVICES WERE RETRIEVED. IT WAS REPORTED THAT WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 15965940 ↗
• MalfunctionDec 13, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED FROM CANADA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CUTTER DEVICE BROKE. A SECOND, SPARE DEVICE WAS OPENED, AND THAT DEVICE BROKE AS WELL. A THIRD, SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE BROKEN PIECES OF THE DEVICES WERE RETRIEVED. IT WAS REPORTED THAT WAS A FIVE MINUTE DELAY TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 15965937 ↗
• InjuryApr 8, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE A BURR DEVICE BROKE AND REMAINED IN THE PATIENT. ACCORDING TO THE REPORTER, THE BROKEN PIECE WAS DISCOVERED POST PROCEDURE BY SCAN AND A SECOND SURGERY WAS PERFORMED TO REMOVE THE BURR PIECE. THE PATIENTS POST OPERATIVE STATUS WAS UNKNOWN. IT WAS NOT REPORTED IF THERE WAS PROLONGED HOSPITALIZATION DUE TO THE EVENT. IT WAS REPORTED THAT THE BURR DEVICE, THE BROKEN PIECE, AND THE PACKAGING WERE ALL DISCARDED. 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 11633376 ↗
• MalfunctionJan 8, 2019Fracture; Fracture

  THIS IS REPORT 2 OF 2 OF THE SAME EVENT. IT WAS REPORTED THAT THE DURING AN UNSPECIFIED SURGICAL PROCEDURE, TWO CUTTER DEVICES BROKE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE HAD A BROKEN TIP. 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. IT WAS NOT REPORTED IF THERE WERE ANY 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 8227484 ↗
• MalfunctionJan 8, 2019Fracture; Fracture

  THIS IS REPORT 1 OF 2 OF THE SAME EVENT. IT WAS REPORTED THAT THE DURING AN UNSPECIFIED SURGICAL PROCEDURE, TWO CUTTER DEVICES BROKE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE HAD A BROKEN TIP. 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. IT WAS NOT REPORTED IF THERE WERE ANY 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 8227478 ↗
• MalfunctionJan 4, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED WHETHER A 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 Consequences Or Impact To Patient

  MAUDE report 7164592 ↗

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-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; 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-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; For cutting and 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-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-2289-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-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-2290-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
• Z-2305-2015 · Apr 13, 2015 · Terminated
  ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-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-2282-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-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-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-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.

…and 24 more.