NA 698325390Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034229652), received between Nov 9, 2018 and Dec 19, 2018 — 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, 2018Break; Break

  MEDWATCH FORM RECEIVED FROM FDA. UF/REPORTER # (B)(4). IT WAS REPORTED DURING A DEPUY SPINE CASE, 7MM SHAVER BROKE IN 2 PIECES. BOTH PIECES WERE IMMEDIATELY RETRIEVED AND INTRA-OP X-RAY WAS OBTAINED. X-RAY READ BY RADIOLOGY ATTENDING, WHO CONFIRMED THAT NO FOREIGN BODY WAS RETAINED FROM BROKEN INSTRUMENT. RADIOLOGIST SPOKE TO DOCTOR, X-RAY WAS CLEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8181445 ↗
• MalfunctionNov 9, 2018Break

  DURING CASE A DEPUY SPINE 7MM SHAVER BROKE INTO 2 PIECES. BOTH PIECES WERE IMMEDIATELY RETRIEVED & INTRA-OP X-RAY WAS OBTAINED. X-RAY READ BY RADIOLOGY ATTENDING, WHO CONFIRMED THAT NO FOREIGN BODY WAS RETAINED FROM BROKEN INSTRUMENT. RADIOLOGIST SPOKE TO DOCTOR, X-RAY WAS CLEAR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8054610 ↗