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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE POWERTEK II PLUS SHAVER ARTHROSCOPE

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BIOMET SPORTS MEDICINE POWERTEK II PLUS SHAVER ARTHROSCOPE Back to Search Results
Model Number N/A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2016
Event Type  malfunction  
Manufacturer Narrative
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event.
 
Event Description
During a procedure, the arthroscope powerpump would not properly function. Another device was used to complete the procedure.
 
Manufacturer Narrative
This follow-up report is being submitted to relay corrected information. Upon reassessment of the reported event, it was determined to be not reportable as this component is did not cause serious injury and this type of malfunction has not caused serious injury in the past. The initial report should be voided.
 
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Brand NamePOWERTEK II PLUS SHAVER
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
BIOMET SPORTS MEDICINE
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6215385
MDR Text Key63621806
Report Number0001825034-2016-05517
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
PK020761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number906063
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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