MAUDE Adverse Event Report: BRASSELER U.S.A. MEDICAL, LLC BRASSELER USA SAW BLADES; SURGICAL SAW BLADE

Catalog Number 5022820M0

Device Problems Device Abrasion From Instrument Or Another Object (1387); Metal Shedding Debris (1804)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product returned to evaluate.Per the user facility, it was discarded.

Event Description

While performing total knee arthroscopy (tka), the saw blades seemed to bind up while running through the four in one cutting block, causing scratches on the blade and metal shavings to be produced.The blade was immediately removed and a second blade was opened with the same result.Both blades were sequestered and sent to risk management for reporting, the case was continued using a different manufacturer's blade.There were no issues encountered with the different blade.Event occurred in (b)(6) 2017.No additional information - the facility had discarded blade when contacted.

• Brand Name: BRASSELER USA SAW BLADES
• Type of Device: SURGICAL SAW BLADE
• Manufacturer (Section D): BRASSELER U.S.A. MEDICAL, LLC; 4837 mcgrath st; ventura CA 93003
• Manufacturer (Section G): BRASSELER U.S.A. MEDICAL, LLC; 4837 mcgrath st; ventura CA 93003
• Manufacturer Contact: giovanny espinosa ; one brasseler blvd; savannah, GA 31419
• MDR Report Key: 7474131
• MDR Text Key: 107333110
• Report Number: 2025102-2018-00006
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2022
• Device Catalogue Number: 5022820M0
• Device Lot Number: NP3V6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 72 YR