NA 311.689Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982187529), received between Jun 24, 2020 and Nov 30, 2021 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT A PROCEDURE. IT WAS NOTED THE TIP OF A T-HANDLE CAP BROKE OFF IN A PATIENT DURING SURGERY. THERE WAS NO SURGICAL DELAY NOTED. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) CANN TAP F/6.5MM & 7.3MM CANN SCREWS 275MM/200MM TAP DEPTH. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12903187 ↗
• InjuryJun 24, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2020, THE CANNULATED TAP FOR 6.5MM AND 7.3MM CANNULATED SCREWS BROKE INSIDE THE PATIENT. FRAGMENTS WERE UNABLE TO BE RETRIEVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A CANNULATED TAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 10189995 ↗