MAUDE Adverse Event Report: BRASSELER USA, MEDICAL L.L.C. BRASSELER USA MEDICAL, LLC MILING HANDPIECE; SURGICAL MILING HANDPIECE

Catalog Number 00-5927-040-00

Device Problem Break (1069)

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

Event Date 11/03/2014

Event Type  malfunction  

Event Description

The flat metal plate on the pfj handpiece that the burr rest upon, broke during use as the doctor was burring the anterior femur during a patellofemoral arthroplasty.When this happened, the burr released the created a deepened groove in the pt's bone.This caused the pfj to be over-burred on the lateral side vs the medial side.The doctor was able to stabilize the component with cement to prevent the orientation to be incorrect.

• Brand Name: BRASSELER USA MEDICAL, LLC MILING HANDPIECE
• Type of Device: SURGICAL MILING HANDPIECE
• Manufacturer (Section D): BRASSELER USA, MEDICAL L.L.C.; 4837 mcgrath st; ventura CA 93003
• Manufacturer (Section G): BRASSELER USA, MEDICAL L.L.C.; 4837 mcgrath st; ventura CA 93003
• Manufacturer Contact: kenneth jones ; one brasseler blvd; savannah, GA 31419 ; 9129217501
• MDR Report Key: 4317401
• MDR Text Key: 5212439
• Report Number: 2025102-2014-00004
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00-5927-040-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Date Device Manufactured: 06/09/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 80