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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA) LLC DEPUY SYNTHES DISTAL RADIUS PLATE PLATE, FIXATION, BONE

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SYNTHES (USA) LLC DEPUY SYNTHES DISTAL RADIUS PLATE PLATE, FIXATION, BONE Back to Search Results
Model Number 02.111.531
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 07/02/2021
Event Type  malfunction  
Event Description
Depuy synthes 02. 111. 531 distal radius plate and 03. 1113. 501 guide block was implanted, malfunctioned, removed and replaced on (b)(6) 2021. Fda safety report id # (b)(4).
 
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Brand NameDEPUY SYNTHES DISTAL RADIUS PLATE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES (USA) LLC
MDR Report Key12253858
MDR Text Key264543970
Report NumberMW5102880
Device Sequence Number1
Product Code HRS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/28/2021
3 Devices were Involved in the Event: 1   2   3  
0 Patients were Involved in the Event:
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number02.111.531
Device Catalogue Number02111531
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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