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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 11/28/2015
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
Prior to the start of a procedure, the shaver attachment of the arthroscope powerpump would not properly function. Another device was used to complete the procedure without delay.
 
Manufacturer Narrative
Reported event was confirmed by review of supplier repair records. The device was returned to the supplier. The device visually looked good. The device runs ok, reverse button does not work, vacuum tube is loose and bent. Valve is loose (o-rings worn), some corrosion on pins in connector in. Motor fails hi-pot test on step 2-4, no tvs present. The motor, flex strip, seals, and all o-rings were replaced and tested per procedure. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. Review of the complaint history determined that no further action(s) is/are required. Investigation results concluded that the reported event was due to low resistance in motor and corrosion not related to manufacturing or design. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
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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 Key6215373
MDR Text Key63619123
Report Number0001825034-2016-05524
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 05/18/2017
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 Received05/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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