NA 532.021Recalls & reported problems
Synthes GmbH · SAGITTAL SAW ATTACHMENT · Class 1
Quick summary
This Synthes sagittal saw attachment has 517 adverse event reports, with no deaths and 4 injuries. Many reports describe the attachment overheating, parts detaching or coming loose, losing power and leaking liquid. Many reports say no injuries were reported. No recalls name this device. Reports fell to 33 in the last 12 months from 70 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 521
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 521 adverse event reports that list this exact device (DI 10886982240583), received between Nov 29, 2017 and Sep 18, 2026 — classified as 4 injuries, 517 malfunctions.
The most frequently reported specific device problem is “Excessive Heating” (222 reports).
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.
Reports received per month
Most reported problems
Device problems
- Excessive Heating222
- Detachment of Device or Device Component142
- Complete Loss of Power63
- Leak/Splash59
- Premature Separation36
- Noise, Audible33
- Overheating of Device26
- Mechanical Jam25
Patient problems
- No Clinical Signs, Symptoms or Conditions381
- No Consequences Or Impact To Patient87
- No Known Impact Or Consequence To Patient43
- Not Applicable9
- Burn(s)2
- Foreign Body In Patient1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 521 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Excessive Heating
It was reported that post surgery, the SAGITTAL SAW ATTACHMENT device was heating up. This event did not occur during surgery. There was no human patient involvement as this device is intended for veterinary purposes. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818068 ↗MalfunctionSep 15, 2026Device-Device Incompatibility; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778498 ↗MalfunctionSep 10, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714052 ↗MalfunctionSep 4, 2026Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Environmental Particulates; Excessive Heating
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50609967 ↗MalfunctionJul 30, 2026Device-Device Incompatibility; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081337 ↗MalfunctionMay 11, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE COMPONENT ON THE SAGITTAL SAW ATTACHMENT DEVICE BECAME DETACHED FROM THE HOUSING. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25138073 ↗MalfunctionMay 7, 2026Excessive Heating
IT WAS REPORTED THAT THE SAGITTAL SAW ATTACHMENT DEVICE HEATS UP. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116127 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE KNOB CAME LOOSE ON THE SAGITTAL SAW ATTACHMENT DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056457 ↗MalfunctionApr 28, 2026Excessive Heating
IT WAS REPORTED THAT THE SAW ATTACHMENT DEVICE WAS OVERHEATING DUE TO INTERNAL FRICTION OF PARTS. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF SURGICAL DELAY. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25021023 ↗MalfunctionApr 23, 2026Leak/Splash
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE HAD A LIQUID LEAK. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24965439 ↗MalfunctionApr 14, 2026Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL SAW ATTACHMENT DEVICE FELL APART. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED ALLEGATION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24876523 ↗MalfunctionMar 26, 2026Complete Loss of Power; Excessive Heating
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE HAD HEAT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24705813 ↗MalfunctionMar 26, 2026Detachment of Device or Device Component; Complete Loss of Power
IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL SAW ATTACHMENT DEVICE FELL APART, UNATTACHED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING AFTER SURGERY. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 (B)(6) 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701316 ↗MalfunctionMar 18, 2026Component Missing; Excessive Heating
IT WAS REPORTED THAT DURING POST-SURGERY, IT WAS DISCOVERED THAT THE SAGITTAL SAW ATTACHMENT DEVICE WAS OVERHEATING AND THE EXTENSION WAS MISSING A SEAL INSIDE. THE EVENT WAS NOT RELATED TO SURGERY. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629587 ↗MalfunctionMar 17, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE ROTATING PART OF THE LOCKING MECHANISM ON THE SAW ATTACHMENT DEVICE COMPLETELY DETACHED AND CAME OFF WHICH CAUSED A DISRUPTION TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SPARE DEVICE. THERE WAS A FIVE-MINUTE DELAY IN SURGERY REPORTED. SURGICAL INTERVENTION WAS INITIALLY REPORTED, HOWEVER UPON FOLLOW-UP WITH THE REPORTER, IT WAS NOT REPORTED WHAT/IF ANY SURGICAL INTERVENTION WAS REQUIRED; NO ADDITIONAL INFORMATION REGARDING INTERVENTION WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619885 ↗MalfunctionMar 11, 2026Complete Loss of Power; Excessive Heating
IT WAS REPORTED THAT THE SAW ATTACHMENT DEVICE WOULD GET HOT AND HAD LOW POWER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL DELAY. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24575422 ↗MalfunctionFeb 27, 2026Noise, Audible; Excessive Heating
IT WAS REPORTED THAT POST PROCEDURE IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WAS OVERHEATING AND MAKING A STRANGE NOISE. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 2026. 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 24476041 ↗MalfunctionFeb 25, 2026Noise, Audible; Premature Separation
IT WAS REPORTED THAT DURING AN UNSPECIFIED VETERINARY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SAGITTAL SAW ATTACHMENT DEVICE WAS NOT SAFELY HOLDING THE BLADE DEVICES. THE REPORTER INDICATED THAT DURING THE SURGERY, THE BLADE FLEW OFF NEARLY STRIKING PERSONNEL. THE DEVICE ALSO PRODUCED A VERY LOUD NOISE DURING USE. THE DEVICE WAS UNUSABLE FOR THE REMAINDER OF THE PROCEDURE AND CAUSED NO INJURIES BUT REQUIRED ADDITIONAL TIME. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS INTENDED FOR VETERINARY PURPOSES. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440572 ↗MalfunctionFeb 25, 2026Appropriate Device Problem Term/Code Not Available; Excessive Heating
IT WAS REPORTED THAT THE TRIGGER OF THE SAGITTAL SAW ATTACHMENT WAS LOOSE; HOWEVER, THE PRE-REPAIR INSPECTION FOUND ONLY EXCESSIVE HEAT GENERATION. THE EVENT WAS NOT RELATED TO SURGERY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS INTENDED FOR VETERINARY PURPOSES. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440050 ↗MalfunctionFeb 20, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE SAGITTAL SAW ATTACHMENT DEVICE BLADES KEPT FALLING OUT DURING USE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403217 ↗MalfunctionFeb 9, 2026Excessive Heating
IT WAS REPORTED THAT THE SAW ATTACHMENT DEVICE OVERHEATS. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293535 ↗MalfunctionFeb 6, 2026Excessive Heating
IT WAS REPORTED THAT THE SAGITTAL SAW ATTACHMENT DEVICE WAS GETTING HOT AFTER ABOUT 5 SECONDS OF USE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. 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 24283037 ↗MalfunctionFeb 4, 2026Premature Separation
IT WAS REPORTED THAT THE SAW ATTACHMENT DEVICE BLADE WILL LOCK AND STAY BUT FALLS OUT WHEN PRESSURE IS APPLIED. THE ISSUE WAS OBSERVED DURING SURGERY. THERE WAS NO HUMAN PATIENT INVOLVEMENT AS THIS DEVICE IS INTENDED FOR VETERINARY PURPOSES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24259922 ↗MalfunctionJan 29, 2026Complete Loss of Power; Excessive Heating
IT WAS REPORTED THAT DURING POST-SURGERY, THE SAGITTAL SAW ATTACHMENT DEVICE OVERHEATED AND EXPERIENCED INTERMITTENT STOPPAGE. THE EVENT WAS NOT RELATED TO SURGERY. 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 JANUARY 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24208772 ↗MalfunctionJan 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE SAGITTAL SAW ATTACHMENT DEVICE RUBBER RING OF THE LOCKING KNOB WAS DETACHED. THERE ARE REPORTS OF DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24176805 ↗
Other INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices
- NA 511.701Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2,164 reports
- SmartLife 7126-120-000Stryker Corporation · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1,065 reports
- NA 05.001.224Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT987 reports
- NA 05.001.206Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT632 reports
- NA 2570-04-501Depuy (Ireland) · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT500 reports
- NA 532.110Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT433 reports
- NA 05.001.223Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT397 reports
- NA 532.022Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT356 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.