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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POWERTEK II PLUS SHAVER HP ARTHROSCOPE

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ZIMMER BIOMET, INC. POWERTEK II PLUS SHAVER HP ARTHROSCOPE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Patient Involvement (2645)
Event Date 05/25/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Foreign-(b)(6). It is unknown if the product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.
 
Event Description
It was reported that the device does not function properly. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NamePOWERTEK II PLUS SHAVER HP
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8239684
MDR Text Key132846860
Report Number0001825034-2019-00157
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K020761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number906063
Device Lot Number71619
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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