Silver Bullet® 1882905HRERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000036782), received between Mar 31, 2020 and Jun 1, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Aug 31, 2021Class IIOpen, Classified

   There was an increase in complaints related to tip breaks and wobble/vibration.

   Z-0156-2022 · Root cause: Process control · Recall details · FDA record ↗

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.

• InjuryJun 1, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT A SILVER BULLET BLADE WAS USED TO TRIM THE SINUS TURBINATE AND THE PIECE INSIDE THE BLADE BROKE OFF. THEY REPLACED WITH ANOTHER BLADE WITH THE SAME LOT NUMBER AND IT BROKE AS WELL. AN X RAY WAS DONE AS PROTOCOL AT THE END OF THE CASE TO MAKE SURE NOTHING WAS IN THE NOSE; IT WAS CONFIRMED THAT NOTHING REMAINED IN THE NOSE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) WITH 30MINS DELAY. THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP IT WAS REPORTED THAT X-RAY WAS DONE SPECIFICALLY TO CHECK FOR FRAGMENTS. THE PART OF THE BLADE THAT BROKE WAS DISTAL TIP. THERE WERE FRAGMENTS DETACHED FROM THE BROKEN BLADE THAT FELL INTO THE PATIENT. THE ANESTHESIA HAD TO DELAY WAKING THE PATIENT UP SO AN X-RAY COULD BE PERFORMED TO MAKE SURE NO FRAGMENTS REMAINED IN THE SINUSES.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11913137 ↗
• InjuryJun 1, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT A SILVER BULLET BLADE WAS USED TO TRIM THE SINUS TURBINATE AND THE PIECE INSIDE THE BLADE BROKE OFF. THEY REPLACED WITH ANOTHER BLADE WITH THE SAME LOT NUMBER AND IT BROKE AS WELL. AN X RAY WAS DONE AS PROTOCOL AT THE END OF THE CASE TO MAKE SURE NOTHING WAS IN THE NOSE; IT WAS CONFIRMED THAT NOTHING REMAINED IN THE NOSE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) WITH 30 MINS DELAY. THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP IT WAS REPORTED THAT X-RAY WAS DONE SPECIFICALLY TO CHECK FOR FRAGMENTS. THE PART OF THE BLADE THAT BROKE WAS DISTAL TIP. THERE WERE FRAGMENTS DETACHED FROM THE BROKEN BLADE THAT FELL INTO THE PATIENT. THE ANESTHESIA HAD TO DELAY WAKING THE PATIENT UP SO AN X-RAY COULD BE PERFORMED TO MAKE SURE NO FRAGMENTS REMAINED IN THE SINUSES.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11913124 ↗
• MalfunctionMar 31, 2020Break; Break

  A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE BLADE BROKE INTRA OPERATIVELY. CUSTOMER USED BACK-UP PRODUCT TO COMPLETE THE PROCEDURE WITH NO ISSUES. NO PATIENT INJURY AND NO DELAY IN PROCEDURE. NOTHING BROKE OFF IN PATIENT OR WAS LEFT INSIDE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM REP STATING THAT THE BLADE DID NOT HAVE FRAGMENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9902079 ↗