NA 532.062Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982240941), received between Mar 17, 2021 and Mar 29, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Dull, Blunt; Separation Problem; Dull, Blunt; Separation Problem

  IT WAS REPORTED BY SWITZERLAND THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW BLADE DEVICE WAS REMOVED FROM THE SAGITTAL SAW ATTACHMENT DEVICE AND THE OUTER CUTTING TEETH WERE SLIGHTLY WORN, AND THE SAW BLADE CONTAINED TAPE RESIDUES. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED VISUAL INSPECTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE SAW BLADE WAS STUCK IN THE SAGITTAL SAW ATTACHMENT AND COULD NOT BE DETACHED. 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 13938607 ↗
• MalfunctionAug 4, 2021Dull, Blunt; Separation Problem; Dull, Blunt; Separation Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW BLADE DEVICE WAS STUCK INSIDE THE SAGITTAL SAW ATTACHMENT DEVICE WHEN IT WAS RECEIVED. IT WAS FURTHER DETERMINED THAT THE SAW BLADE WAS ABLE TO BE REMOVED FROM THE SAGITTAL SAW ATTACHMENT. IT WAS FURTHER DETERMINED THAT THE CUTTING TEETH WERE SEVERELY WORN, AND THE SAW BLADE SHOWED DENTS FROM THE REMOVAL AND A LATERAL RIDGE WHICH MOST LIKELY WAS CAUSED BY THE INTERACTION WITH A CUTTING BLOCK DURING USAGE. IT WAS FURTHER OBSERVED THAT THE DEVICE FAILED VISUAL INSPECTION. IT WAS NOTED IN THE SERVICE ORDER THAT THE SAGITTAL SAW ATTACHMENT DEVICE DID NOT WORK ANYMORE WHILE BEING USED TOGETHER WITH THE SAW BLADE DEVICE. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276052 ↗
• MalfunctionJul 7, 2021Separation Problem; Separation Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW BLADE DEVICE WAS JAMMED INSIDE THE SAGITTAL SAW ATTACHMENT DEVICE AND WAS ABLE TO BE RELEASED FROM THE ATTACHMENT. IT WAS FURTHER DETERMINED THAT THERE WERE SEVERE SCRATCHES ON THE SAW BLADE SURFACE WHICH MADE IT IMPOSSIBLE TO READ THE PRODUCT IDENTIFICATION OR LOT NUMBER. IT WAS OBSERVED THAT THE SAW BLADE WAS BENT, THE CUTTING TEETH SHOWED SIGNS OF HEAVY WEAR, AND THE SURFACE WAS HEAVILY SCRATCHED OFF. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED VISUAL INSPECTION. IT WAS NOTED IN THE SERVICE ORDER THAT DURING PRE-SURGERY, IT WAS DISCOVERED THAT THE SAGITTAL SAW ATTACHMENT DEVICE DID NOT WORK ANYMORE AND THE SAW BLADE DEVICE WAS STUCK. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127618 ↗
• MalfunctionMar 17, 2021Dull, Blunt; Dull, Blunt

  IT WAS REPORTED FROM (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SAW BLADE DEVICE SHOWED SLIGHT SIGNS OF WEAR, AND ONE TOOTH ON THE DEVICE SHOWED A DULL EDGE. 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 NOT REPORTED. 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 11507747 ↗