NA 03.118.110Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982073679), received between Apr 1, 2021 and Apr 1, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A SURGICAL PROCEDURE WAS PERFORMED. FOUR (4) DRILL BIT HIT WIRES AND SNAPPED, CLAMP WAS USED, AND THE TIP BROKE OFF. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF 3 MINUTES. IT WAS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRES (PART# UNKNOWN; LOT# UNKNOWN: QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) PERIAORTIC RED FCP 6.5 BALL & PTD TIP/MED. THIS REPORT IS 5 OF 7 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602758 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A SURGICAL PROCEDURE WAS PERFORMED. FOUR (4) DRILL BIT HIT WIRES AND SNAPPED, CLAMP WAS USED, AND THE TIP BROKE OFF. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF 3 MINUTES. IT WAS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRES (PART# UNKNOWN; LOT# UNKNOWN: QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) PERIAORTIC RED FCP 6.5 BALL & PTD TIP/MED. THIS REPORT IS 4 OF 7 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602756 ↗
• MalfunctionApr 1, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, A SURGICAL PROCEDURE WAS PERFORMED. FOUR (4) DRILL BIT HIT WIRES AND SNAPPED, CLAMP WAS USED, AND THE TIP BROKE OFF. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF 3 MINUTES. IT WAS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN K-WIRES (PART# UNKNOWN; LOT# UNKNOWN: QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) PERIAORTIC RED FCP 6.5 BALL & PTD TIP/MED. THIS REPORT IS 1 OF 7 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602754 ↗