Brasseler USA 5007973M0Recalls & reported problems
Peter Brasseler Holdings, LLC · KM172-26-45S K-WIRE .045 X 6" · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887919491057), received between Oct 1, 2024 and Oct 1, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
DURING AN ACHILLES TENDON REPAIR SURGERY, THE DOCTOR WAS INSERTING A 1.1MM K-WIRE INTO THE PATIENT'S CALCANEUS BONE AS AN ANCHOR GUIDE, BUT IT BROKE IN THE MIDDLE, LEAVING 40MM OF THE WIRE LODGED IN THE BONE. HE ATTEMPTED TO REMOVE IT WITH A TONSIL CLAMP AND NEEDLE HOLDER, BUT IT COULDN'T BE EXTRACTED, SO IT WAS DECIDED TO LEAVE IT IN PLACE. NO PATIENT INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20343904 ↗
Other PIN, FIXATION, SMOOTH devices
- RIGIDFIX 210133Medos International Sàrl · PIN, FIXATION, SMOOTH91 reports
- SMART TOE ST0A-16PStryker GmbH · PIN, FIXATION, SMOOTH1 recall5 reports
- SMART TOE ST0-19PStryker GmbH · PIN, FIXATION, SMOOTH1 recall2 reports
- Flower E-Kit, Advanced EWK 201Flower Orthopedics Corporation · Pin, Fixation, Smooth1 recall0 reports
- Brasseler USA 5007972M0Peter Brasseler Holdings, LLC · PIN, FIXATION, SMOOTH1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page