Silver BulletRecalls & reported problems across all models

We found 4 models of Silver Bullet by Medtronic Xomed, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2017 and Jun 1, 2021 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Silver Bullet recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 31, 2021Open, Classified

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

   Z-0156-2022 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported Silver Bullet problems

Silver Bullet models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Silver Bullet® 1882905HRE

  BUR, EAR, NOSE AND THROAT
  1 recall3 reports
• Silver Bullet® 1884005HRE

  BUR, EAR, NOSE AND THROAT
  1 recall0 reports
• Silver Bullet® 1884005HRE

  BUR, EAR, NOSE AND THROAT
  2 reports
• Silver Bullet® 1884005

  BUR, EAR, NOSE AND THROAT
  1 report

Recent Silver Bullet adverse event reports

The 6 most recent reports across all models, 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 ↗
• InjurySep 14, 2020Material Fragmentation; Material Fragmentation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE TIP OF THE BLADE RUPTURED IN THE NASAL CAVITY. THE BROKEN PIECES OF THE REPORTED PRODUCT WAS REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10528224 ↗
• 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 ↗
• MalfunctionJun 15, 2018Break; Break

  DURING USE, THE TIP OF THE INNER SHAFT WAS BROKEN. THERE WERE NO FRAGMENTS. THERE WAS NO PATIENT IMPACT OR INJURY, THE PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7604882 ↗
• MalfunctionJul 24, 2017Break; Break

  THE FACILITY REPORTED THAT THE HEAD OF TWO BLADES FRACTURED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6737123 ↗

Other Medtronic Xomed, Inc. products

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• StraightShot6 models · 546 reports
• NIM15 models · 410 reports · 2 recalls
• ViSAO16 models · 412 reports
• XPS Straightshot2 models · 356 reports