NA 05.001.240Recalls & reported problems

Summary

The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 10886982130150), received between Nov 27, 2017 and Sep 30, 2026 — classified as 262 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (97 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. 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 25 most recent of 262 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949076 ↗
• MalfunctionApr 13, 2026Intermittent Loss of Power

  IT WAS REPORTED THAT THE RECON SAGITTAL SAW WITH KEY FOR TRS DEVICE WOULD TIGHTEN/FREEZE RANDOMLY. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 24860867 ↗
• MalfunctionApr 13, 2026Intermittent Loss of Power

  IT WAS REPORTED THAT THE SAGITTAL SAW DEVICE WAS FREEZING RANDOMLY. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24860776 ↗
• MalfunctionMar 24, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION AND NEEDED REPAIR. 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 24673745 ↗
• MalfunctionMar 13, 2026Intermittent Loss of Power

  IT WAS REPORTED THAT THE RECON SAGITTAL SAW WITH KEY FOR TRS DEVICE OPERATES INTERMITTENTLY WHILE IN USE WITH THE LID DEVICE. 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 24598319 ↗
• MalfunctionMar 10, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE TRIGGER DID NOT MOVE SMOOTHLY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK ANYMORE. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558370 ↗
• MalfunctionFeb 27, 2026Mechanical Jam; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL SAW WITH KEY DEVICE HAD A STICKY TRIGGER, SEIZED BEARING, FAILED THE LEAK TIGHTNESS TEST, WOULD NOT RUN, AND HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK GENERAL CONDITION, LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR STICKY TRIGGERS, CHECK FALLING OUT PROTECTION, CHECK GENERAL FUNCTION OF DEVICE, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DEFECTIVE. 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 24474589 ↗
• MalfunctionFeb 27, 2026Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNSPECIFIED 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470348 ↗
• MalfunctionFeb 27, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470092 ↗
• MalfunctionFeb 9, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE MOVING PARTS DID NOT MOVE SMOOTHLY - TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291838 ↗
• MalfunctionFeb 4, 2026Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW ATTACHMENT DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256805 ↗
• MalfunctionJan 22, 2026Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL SAW WITH KEY DEVICE HAD A STICKY TRIGGER, WOULD NOT RUN, THE BEARING SEIZED, AND THE DEVICE FAILED THE LEAK TIGHTNESS TEST. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR STICKY TRIGGER, CHECK ROUNDNESS OF HOUSING, CHECK FALLING OUT PROTECTION, CHECK FITTING WITH LID, CHECK GENERAL FUNCTION OF DEVICE, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. 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 2025. 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 24144243 ↗
• MalfunctionDec 23, 2025Appropriate Device Problem Term/Code Not Available; Intermittent Loss of Power; Appropriate Device Problem Term/Code Not Available; Intermittent Loss of Power

  IT WAS REPORTED THAT THE ATTACHMENT DEVICE WAS WORKING INTERMITTENTLY, WITH FLUCTUATING POWER LEVELS. TESTS HAVE BEEN PERFORMED WITH DIFFERENT BATTERIES, BUT THE PROBLEM PERSISTS. 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 23876561 ↗
• MalfunctionDec 12, 2025Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAGITTAL SAW WITH KEY DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. 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 2025. 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 23794789 ↗
• MalfunctionNov 5, 2025Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECON SAGITTAL SAW WITH KEY FOR TRS DEVICE WAS HAD A STICKY TRIGGER 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 23480241 ↗
• MalfunctionOct 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECON SAGITTAL SAW WITH KEY FOR TRS DEVICE HAD A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD SEIZED BEARING, LEAK TIGHTNESS TEST FAILURE, COMPONENT DAMAGED, AND WILL NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED THE FOLLOWING PRETEST STEPS: GENERAL CONDITION, LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR STICKY TRIGGER, CHECK GENERAL FUNCTION OF DEVICE, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE NEEDED REPAIR. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414311 ↗
• MalfunctionOct 20, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE RECON SAGITTAL SAW WITH KEY FOR TRS DEVICE HAD A STICKY TRIGGER. IT WAS FURTHER DETERMINED THE DEVICE HAD A SEIZED BEARING, LEAK TIGHTNESS TEST FAILURE, CANNOT ENGAGE ATTACHMENT - COUPLING, AND WILL NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED THE FOLLOWING PRETEST STEPS: LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK COUPLING SCREW OF SAW BLADE COUPLING, CHECK SAW BLADE COUPLING, CHECK FOR STICKY TRIGGER, CHECK ROUNDNESS OF HOUSING, CHECK FITTING WITH LID, CHECK GENERAL FUNCTION OF DEVICE, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS DEFECTIVE. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342397 ↗
• MalfunctionSep 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS NOTED IN THE SERVICE ORDER THAT THE SAGITTAL SAW DEVICE HAD AN UNDETERMINED MALFUNCTION. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD A SEIZED BEARING, LEAK TIGHTNESS TEST FAILURE, AND WOULD NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR STICKY TRIGGER, CHECK GENERAL FUNCTION OF DEVICE AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976496 ↗
• MalfunctionSep 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS NOTED IN THE SERVICE ORDER THAT THE SAGITTAL SAW DEVICE HAD AN UNDETERMINED MALFUNCTION. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A WORN BEARING, COMPONENT DAMAGE, LEAK TIGHTNESS TEST FAILURE, WOULD NOT RUN NOR HOLD/SECURE THE BATTERY, WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE AND THE SAW HEAD COULD NOT BE ROTATED OR LOCKED IN THE NEW POSITION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK COUPLING SCREW OF SAW BLADE COUPLING, CHECK SAW BLADE COUPLING, CHECK SAW HEAD¿S LOCKING MECHANISM, CHECK ROTATING MECHANISM OF SAW HEAD, CHECK FOR STICKY TRIGGER, CHECK ROUNDNESS OF HOUSING, CHECK FALLING OUT PROTECTION, CHECK FITTING WITH LID, CHECK FOR WEAR ON HOUSING, CHECK GENERAL FUNCTION OF DEVICE AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954905 ↗
• MalfunctionAug 21, 2025Physical Resistance/Sticking; Complete Loss of Power; Physical Resistance/Sticking; Complete Loss of Power

  IT WAS NOTED IN THE SERVICE ORDER THAT THE SAGITTAL SAW DEVICE DID NOT WORK AFTER SURGERY. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD A SEIZED BEARING AND WOULD NOT HOLD/SECURE THE BATTERY NOR RUN. IT WAS OBSERVED THAT THE DEVICE WAS DIFFICULT TO ASSEMBLE/DISASSEMBLE, HAD A LEAK TIGHTNESS TEST FAILURE AND THE LOCKING MECHANISM WAS STIFF/STUCK. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK SAW BLADE COUPLING, CHECK SAW HEAD¿S LOCKING MECHANISM, CHECK FOR STICKY TRIGGER, CHECK FALLING OUT PROTECTION, CHECK GENERAL FUNCTION OF DEVICE AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865622 ↗
• MalfunctionAug 12, 2025Unintended System Motion; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Unintended System Motion; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  IT WAS REPORTED THAT THE RECON SAGITTAL SAW DEVICE WAS WORKING WITHOUT BEING CONTROLLED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF A DELAY 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786667 ↗
• MalfunctionJul 10, 2025Mechanical Jam; Noise, Audible; Intermittent Loss of Power; Mechanical Jam; Noise, Audible; Intermittent Loss of Power

  IT WAS REPORTED THAT THE RECON SAGITTAL SAW ATTACHMENT DEVICE WORKED WITH NOISES AND WAS WORKING INTERMITTENTLY. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE WOULD NOT OSCILLATE AND HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK COUPLING SCREW OF SAW BLADE COUPLING AND CHECK GENERAL FUNCTION OF DEVICE. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 22466433 ↗
• MalfunctionJul 9, 2025Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE RECON SAGITTAL SAW WITH KEY FOR TRS DEVICE WORKS RANDOMLY (OPERATED INTERMITTENTLY). THERE WAS A FIFTEEN MINUTE 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 22455854 ↗
• MalfunctionJun 27, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  IT WAS NOTED IN THE SERVICE ORDER THAT AFTER SURGERY, IT WAS FOUND THAT THE PLASTIC CASE ON THE SAGITTAL SAW DEVICE WAS BROKEN. THERE WERE NO SURGICAL DELAYS. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD CRACKED/DAMAGED HOUSING, LEAK TIGHTNESS TEST FAILURE AND WOULD NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR STICKY TRIGGER, CHECK ROUNDNESS OF HOUSING, CHECK FALLING OUT PROTECTION, CHECK FITTING WITH LID, CHECK FOR WEAR ON HOUSING, CHECK GENERAL FUNCTION OF DEVICE AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 22345965 ↗
• MalfunctionJun 26, 2025Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking; Appropriate Device Problem Term/Code Not Available; Physical Resistance/Sticking

  IT WAS NOTED IN THE SERVICE ORDER THAT THE SAGITTAL SAW DEVICE HAD AN UNDETERMINED MALFUNCTION. DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE HAD A LEAK TIGHTNESS TEST FAILURE, WORN BEARING, WOULD NOT RUN, AND THE MOVING PARTS DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR LEAKAGE TEST USING BUBBLE EMISSION TECHNIQUE, CHECK FOR STICKY TRIGGER, CHECK FALLING OUT PROTECTION, CHECK GENERAL FUNCTION OF DEVICE AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. 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 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340071 ↗