NA 702877Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540413901), received between Dec 3, 2018 and Jan 8, 2019 — classified as 1 injury, 1 malfunction.

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.

• InjuryJan 8, 2019Break; Improper or Incorrect Procedure or Method

  DRILL WAS BROKE DURING DRILLING THE BACKWARD OF THE PELVIS BONE AND IT WAS LEFT IN THE PATIENT BODY. DURING OPERATION, NURSE INCORRECTLY INSERTED THE 3.5MM DEPTH GAUGE WAS INSERTED INTO THE 4,5MM/6.5 MM DEPTH GAUGE EXTERNAL CYLINDER AND THE DOCTOR PERFORATED THE PELVIS. THE DOCTOR REQUEST : SINCE THERE IS NO MARK OF DIFFERENCE IN SIZE, IT IS NOT NOTICED EVEN IF IT IS WRONG. TIP OF THE DRILL WAS LEFT IN THE PATIENT BODY.

  Patient problems: Internal Organ Perforation

  MAUDE report 8228628 ↗
• MalfunctionDec 3, 2018Incorrect Measurement

  DURING PELVIC SURGERY THE LONG INNER PORT OF 702877 WAS INSERTED IN THE OUTER PORT OF 702876 WHICH RESULTED IN A TOO LONG MEASUREMENT. DURING INSERTION OF THE SCREW THE MISTAKE WAS DETECTED. CUSTOMER STATED THAT THERE IS NO NUMBER ON THE INNER PORT TO VERIFY WHICH PORTS OF THE 2 DEVICES BELONG TOGETHER. SURGICAL DELAY OF 5 MIN. NOT LONGER. NO OTHER CONSEQUENCES REPORTED. THE CUSTOMER STATED THAT THERE IS A POSSIBILITY OF HAZARD IF WRONG MEASUREMENT IS NOT DETECTED. IN THIS CASE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8126109 ↗