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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. POWERTEK II PLUS SHAVER HANDPIECE ARTHROSCOPE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Upon reassessment of the reported event, it was determined to be not reportable. The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number. This event will be reported on 0001825034-2017-09701. The following sections were {updated/corrected}.
 
Manufacturer Narrative
(b)(4). Concomitant product(s): part #:906063 lot:# 71635. Part #:906063 lot:# 71569. Part #:906063 lot:# 71624. Report source: foreign: (b)(6) customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-08284, 0001825034-2017-08285, 0001825034-2017-08288.
 
Event Description
It was reported that during an unknown procedure, four devices created unknown problems. No adverse events have been reported as a result of the malfunction. Attempts have been made to gather information but no further information has been provided.
 
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Brand NamePOWERTEK II PLUS SHAVER HANDPIECE
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 Key6937553
MDR Text Key192950409
Report Number0001825034-2017-08286
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
PK020761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 03/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number906063
Device Lot Number71574
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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