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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 08/03/2016
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 without delay.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of repair work order documentation from the supplier. Review of the dhr indicates this device was previously repaired. The motor was non-functional/non-responsive. Inside of device was packaged with contamination and irrigation path was clogged. The motor was replaced as well as damaged spacers, seal head, face seal, and all o-rings. Device was cleaned, reassembled and tested per then-current procedures. Device was returned to supplier for a second time and examined. Corrosion was noted in connector end. Cable outer casing is cracked in several places. The device fails current draw testing. The shaft face has lifted surface. The cable, motor, seal, and all o-rings were replaced and device tested per procedure. Review of the complaint history determined that no further action(s) is/are required. Investigation results concluded that the reported event was due to bad motor, corrosion and damaged cable. 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 Key6215798
MDR Text Key63653006
Report Number0001825034-2016-05522
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,health profe
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2017
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
Device Lot Number084820
Other Device ID NumberN/A
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 Received05/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2015
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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