NA 03.605.520Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034712604), received between Mar 30, 2017 and Nov 16, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A SPINAL ARTHRODESIS, THE LAMINECTOMY PUNCH WAS NOT ARRANGED CORRECTLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/254MM LENGTH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819798 ↗
• MalfunctionMar 30, 2017Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED THAT DURING CLEANING IT WAS NOTED THE UP-BITING LAMINECTOMY PUNCH IS NOT FUNCTIONING PROPERLY. CLOSER INSPECTION NOTED THE INNER PART THAT PUSHES BONE OUT OF THE INSTRUMENT WAS BROKEN. THE BROKEN PIECE HAS BEEN DISCARDED. NO PATIENT OR SURGERY INVOLVEMENT. THIS REPORT IS FOR ONE (1) UP-BITING LAMINECTOMY PUNCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6447982 ↗