• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET SPORTS MEDICINE POWERTEK II PLUS HP ONLY ARTHROSCOPE Back to Search Results
Catalog Number 906063
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2016
Event Type  malfunction  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of repair records received from supplier. The device was returned to supplier. Visually the device is ok, broken lanyard. Corrosion in connector end, buttons don't work, won't run/motor frozen, fails hi-pot on step 2-4, cable passes hi-pot. The motor, flex strip, seals, and all o-rings were replaced and the device was 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 is required. Root cause was determined to be bad motor, rust 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.
 
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.
 
Event Description
During a procedure, the shaver attachment did not work. There was no harm to the patient or operator. Surgery was not delayed due to this malfucntion.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOWERTEK II PLUS HP ONLY
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 Key6215403
MDR Text Key130230347
Report Number0001825034-2016-05469
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2017
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 Catalogue Number906063
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 Received07/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberNI

-
-