NA 5450815114Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613252518402), received between Jul 2, 2018 and Apr 22, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Fracture” (19 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954355 ↗
• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163598 ↗
• MalfunctionJul 29, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 3 EVENTS FOR THE FAILURE: FRACTURE. 3 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647441 ↗
• MalfunctionJan 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18555901 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985874 ↗
• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397361 ↗
• MalfunctionFeb 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING SET-UP FOR A PROCEDURE, WHEN PRIMING, THE TIP WAS BROKEN. IT WAS FURTHER REPORTED THAT THERE WAS NO DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416229 ↗
• MalfunctionDec 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15904101 ↗
• MalfunctionJul 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE SONOPET KNIFE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR USER AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14993551 ↗
• MalfunctionJul 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP BROKE ON THREE DEVICES WITHIN THE SAME PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE REPORTED INSTANCES OF THE TIP BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982010 ↗
• MalfunctionJul 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP BROKE ON THREE DEVICES WITHIN THE SAME PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE REPORTED INSTANCES OF THE TIP BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981948 ↗
• MalfunctionJul 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP BROKE ON THREE DEVICES WITHIN THE SAME PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE REPORTED INSTANCES OF THE TIP BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14981902 ↗
• MalfunctionJul 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14933923 ↗
• MalfunctionAug 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE TIP BROKE DURING A LOWER JAW SURGICAL PROCEDURE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359670 ↗
• MalfunctionApr 23, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP BROKE OFF AND WAS REMOVED. IT WAS FURTHER REPORTED THAT THERE WAS A TWO MINUTE DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716021 ↗
• MalfunctionApr 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT AFTER A SSRO (SAGITAL SPLIT RAMUS OSTEOTOMY) SURGICAL PROCEDURE, IT WAS OBSERVED THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648023 ↗
• MalfunctionMar 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE DEVICE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527316 ↗
• MalfunctionJan 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11161946 ↗
• MalfunctionOct 20, 2020Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO A SURGICAL PROCEDURE, THE TIP OF THE DEVICE BROKE DURING DEVICE ASSEMBLY. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10707892 ↗
• MalfunctionSep 17, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE, IT WAS NOTED THAT THERE WAS A HAIR IN THE PACK DURING VISUAL INSPECTION. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10550596 ↗
• MalfunctionDec 9, 2019Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH REPORT # 0501120000-2019-8008 THAT THE TIP BROKE INTO 2 PIECES DURING A LEFORT 1, BILATERAL SAGITTAL SPLIT OSTEOTOMY PROCEDURE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REPLACEMENT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437993 ↗
• MalfunctionNov 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORAL PLATE FIXATION SURGERY THAT THE TIP BROKE AND WAS REMOVED. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318124 ↗
• MalfunctionJul 23, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8816022 ↗
• MalfunctionApr 24, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546058 ↗
• MalfunctionJan 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD A BROKEN CUTTING ACCESSORY STILL ATTACHED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285187 ↗