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U.S. Department of Health and Human Services

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

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BRASSELER U.S.A. MEDICAL, LLC BONE SAW BLADE SAGITTAL; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Back to Search Results
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.
 
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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 Key7330197
MDR Text Key102079993
Report Number7330197
Device Sequence Number1
Product Code GFA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberBR1-1290-35
Device Catalogue NumberBR1-1290-35
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/06/2018
Event Location Hospital
Date Report to Manufacturer03/06/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
IT IS UNKNOWN IF OTHER DEVICES WERE BEING USED ON
Patient Age60 YR
Patient Weight114
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