NA S-5DX-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845384012689), received between Jul 22, 2019 and Mar 20, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO SURGERY IT WAS OBSERVED THAT THE CUTTER DEVICE COULD NOT BE ATTACHED TO THE SHORT ATTACHMENT DEVICE NOR OTHER ATTACHMENTS. IT WAS FURTHER REPORTED THAT THE DIAMOND BALL IN QUESTION COULD NOT BE ATTACHED TO THE SHORT ATTACHMENT NOR TO OTHER ATTACHMENTS. ANOTHER DIAMOND BALL WAS ATTACHED TO THE SHORT ATTACHMENT DEVICE AND OTHER ATTACHMENT DEVICES WITH NO PROBLEM. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS DAMAGED AND THERE WAS A CUT ON THE SURFACE NEAR THE PROXIMAL OF THE CUTTER WHICH KEPT IT FROM GOING THRU THE ATTACHMENT DEVICE. PHOTOS SHOWED THAT THE DEVICE WAS HIT BY A FOREIGN OBJECT. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO 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 16572096 ↗
• MalfunctionJul 22, 2019Vibration; Vibration

  IT WAS REPORTED FROM (B)(6) THAT DURING AN INTRACRANIAL TUMOR REMOVAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE TIP ROTATED ECCENTRICALLY WITH SOME NOISE. IT WAS REPORTED THAT THE HANDPIECE AND THE ATTACHMENT HAD NO ISSUE. IT WAS REPORTED THAT A SPARE DEVICE WAS AVAILABLE TO USE AND THE PROCEDURE WAS COMPLETED WITHOUT ANY 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 Consequences Or Impact To Patient

  MAUDE report 8812520 ↗

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-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-2284-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Acorn, 7MM REF L-7AC-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-2311-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-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-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-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-2299-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 7MM Fluted Acorn; REF M-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-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-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-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.

…and 24 more.