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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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11 records meeting your search criteria returned- Product Code: HWE Patient Problem: Failure of Implant Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ARTHREX, INC. FLIPCUTTER II, SHORT 10MM 09/12/2023
ARTHREX, INC. 9.0 MM FLIP CUTTER II 12/21/2021
ZIMMER BIOMET, INC. PATELLO-FEMORAL JOINT (PFJ) MILLING BURR 11/16/2021
Unknown Manufacturer FLIPCUTTER II, SHORT 10.5MM 10/19/2021
ARTHREX, INC. 9.5 MM FLIP CUTTER II 02/01/2021
NOVASTEP NEXIS T25-S 1/4" SCREWDRIVER TIP 07/10/2020
ARTHREX, INC. 9.5 MM FLIP CUTTER II 06/06/2019
EXACTECH DRILL BIT 08/09/2017
SYNTHES USA SCREW, FIXATION, BONE 05/09/2016
SYNTHES ELMIRA 2.5MM DRILL BIT/QC/GOLD/180MM 03/20/2015
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