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

Model Number BR1-1290-35

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 02/06/2018

Event Type  malfunction  

Event Description

Elderly female underwent an elective left total knee arthroplasty.Per the report, the brasseler blade was being used during the procedure.When the surgeon began to cut, the blade tooth broke off.The surgeon immediately stopped the procedure.The broken piece was identified and retrieved.The instrument and blade were removed from the surgical field.

• Brand Name: BONE SAW BLADE SAGITTAL
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): BRASSELER U.S.A. MEDICAL, LLC; 4837 mcgrath st.; ventura CA 93003
• MDR Report Key: 7330197
• MDR Text Key: 102079993
• Report Number: 7330197
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2018

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: Physician
• Device Model Number: BR1-1290-35
• Device Catalogue Number: BR1-1290-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: IT IS UNKNOWN IF OTHER DEVICES WERE BEING USED ON
• Patient Age: 60 YR
• Patient Weight: 114