NA 03.505.086Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587013688), received between Dec 19, 2019 and Dec 19, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A SSRO SURGERY ON (B)(6) 2019, THE 2 DRILL BITS (03.505.086) WERE BROKEN WHEN DRILLING LEFT SIDE AFTER THE RIGHT. THE SURGERY WAS COMPLETED AND THERE WAS NO HARM TO THE PATIENT. IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. CONCOMITANT DEVICE REPORTED: UNKNOWN HAND PIECE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9498205 ↗
• MalfunctionDec 19, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A SSRO SURGERY ON (B)(6) 2019, THE 2 DRILL BITS (03.505.086) WERE BROKEN WHEN DRILLING LEFT SIDE AFTER THE RIGHT. THE SURGERY WAS COMPLETED AND THERE WAS NO HARM TO THE PATIENT. IT WAS UNKNOWN WHETHER THERE WAS A SURGICAL DELAY OR NOT. CONCOMITANT DEVICE REPORTED: UNKNOWN HAND PIECE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9498201 ↗