NA 316.290Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982189578), received between Jan 28, 2019 and Jan 28, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, A DRILL BIT WOULD NOT FIT INTO THE TPS DRILL. A SECOND UNKNOWN DRILL WAS BROUGHT IN TO SEE IF THE DRILL WAS BROKEN AND REALIZED IT WAS THE DRILL BIT THAT WOULD NOT FIT IN, SO THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT ANY ISSUES USING A SIMILAR DRILL BIT WITH DIFFERENT LINK. THERE WAS A SURGICAL DELAY OF 5 TO 7 MINUTES. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: UNKNOWN DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 0.76MM DRILL BIT/MINI QC WITH 10MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8282722 ↗