NA S-SAWRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00845384008521), received between Mar 11, 2022 and Oct 26, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (4 reports).

35 other recalls cover devices cleared under the same FDA submission (K080802); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2022Break; Appropriate Device Problem Term/Code Not Available; Excessive Heating; Break; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED BY JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS GENERATING HEAT. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD VIBRATION AND WAS MAKING UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD WORN BEARING AND MALFUNCTION. 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 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672027 ↗
• MalfunctionOct 6, 2022Excessive Heating; Difficult or Delayed Separation; Excessive Heating; Difficult or Delayed Separation

  IT WAS REPORTED BY JAPAN THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL MICROSAW ATTACHMENT DEVICE GENERATED HEAT AND EXPERIENCED VIBRATION. IT WAS FURTHER OBSERVED THAT THE DEVICE WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE, WAS STUCK IN CONNECTION, AND MADE AN UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR ATTACHMENT ENGAGEMENT ASSESSMENT AND TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DIFFICULT TO CONNECT AND REMOVE. 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 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550293 ↗
• MalfunctionMay 6, 2022Excessive Heating; Difficult or Delayed Separation; Excessive Heating; Difficult or Delayed Separation

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL MICRO SAW DEVICE BEARING WAS WORN, WOULD NOT ENGAGE ATTACHMENT, MADE UNEXPECTED NOISE, VIBRATING AND HEATING UP . IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETESTS FOR ATTACHMENT ENGAGEMENT ASSESSMENT AND TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DIFFICULT TO CONNECT AND REMOVE SMOOTHLY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN (B)(6) 2022. 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 14305224 ↗
• MalfunctionMar 11, 2022Appropriate Device Problem Term/Code Not Available; Excessive Heating; Appropriate Device Problem Term/Code Not Available; Excessive Heating

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ATTACHMENT DEVICE WAS GENERATING HEAT. IT WAS FURTHER OBSERVED THAT THE DEVICE HAD WORN BEARING, WAS VIBRATING AND WAS MAKING UNEXPECTED NOISE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR TEMPERATURE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. 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 BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13737103 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080802. One submission often covers many models, so check the product and lot details in each record.

• Z-1952-2017 · Oct 6, 2016 · Terminated
  eMax2 PLUS Product Usage: Electric system
• Z-2031-2017 · Oct 6, 2016 · Terminated
  Sagittal MICRO-SAW
• Z-2015-2017 · Oct 6, 2016 · Terminated
  Sagittal Saw Product Usage: Pneumatic system
• Z-1949-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
• Z-1956-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, with irrigation Product Usage: Electric system
• Z-1957-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, no irrigation
• Z-2001-2017 · Oct 6, 2016 · Terminated
  12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
• Z-1955-2017 · Oct 6, 2016 · Terminated
  Console, eMax2 Plus Product Usage: Electric system
• Z-2019-2017 · Oct 6, 2016 · Terminated
  Oscillating MICRO-SAW Product Usage: Pneumatic system
• Z-2032-2017 · Oct 6, 2016 · Terminated
  20.2cm Heavy Duty Long Heavy Short Attachment
• Z-1948-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction Switch Product Usage: Electric system
• Z-2026-2017 · Oct 6, 2016 · Terminated
  Reciprocating MICRO SAW
• Z-0729-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and
• Z-0727-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM C
• Z-0726-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 1

…and 20 more.