NA 03.505.041Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587013497), received between Feb 16, 2017 and Jul 9, 2025 — classified as 4 malfunctions.

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

• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A SSRO TREATING THE MANDIBLE. DURING THE SURGERY, THE DRILL BIT GOT BROKEN. THERE WAS NO IMPACT ON THE SURGERY SINCE A SPARE PRODUCT WITH THE SAME PRODUCT CODE WAS USED IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22459939 ↗
• MalfunctionApr 27, 2023No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN UNKNOWN SURGERY WHEN THE SURGEON TURNED THE SHAFTS OUTSIDE THE PATIENT¿S BODY BEFORE USE, THE SHAFTS BROKE LIKE THEY SPLATTER. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR A 1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16826589 ↗
• MalfunctionJun 8, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A DRILL BIT AND 2.0MM TITANIUM MATRIX MANDIBLE SCREW THAT WAS BROKEN. A BROKEN DRILL BIT WAS A 1.5 DRILL BIT FOR THE 90-DEGREE SCREWDRIVER SELF-TAPPING MANDIBLE AND THE SCREW WITH 2.0 SCREW 8MM LENGTH AND THE DRILL BIT WAS A DRILL BIT AND THE SCREWDRIVER BROKE FOR THIS ADVERSE EVENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.   THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962763 ↗
• MalfunctionFeb 16, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGERY WAS PERFORMED FOR THE TREATMENT OF MAXILLA AND MANDIBULAR DEFORMITY PATIENT ON (B)(6) 2017. WHEN THE SURGEON WAS ATTEMPTING TO FIX THE MANDIBLE BY USING A CONTRA-ANGLE DRIVER AND A DRILL-TIP, THE DRILL-TIP WAS BROKEN. THERE IS NO BROKEN FRAGMENT LEFT IN THE PATIENT¿S BODY. THIS COMPLAINT INVOLVES 1 PART. THERE IS NO INFORMATION AVAILABLE ABOUT PATIENT OUTCOME. PROCEDURE WAS SUCCESSFULLY COMPLETED, NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THERE IS A SURGICAL PROLONGATION REPORTED BUT UNKNOWN HOW MANY MINUTES. CONCOMITANT DEVICE: 1X UNK CONTRA-ANGLE DRIVER. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6336412 ↗