MAUDE Adverse Event Report: BRASSELER U.S.A. MEDICAL, LLC BLADE BRASSELER; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number KM3 225

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2020

Event Type  malfunction  

Event Description

Saw blade broke while in use in drill.Fda safety report id# (b)(4).

• Brand Name: BLADE BRASSELER
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): BRASSELER U.S.A. MEDICAL, LLC
• MDR Report Key: 10332040
• MDR Text Key: 200803436
• Report Number: MW5095741
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KM3 225
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 97