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

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

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 Information (3190)
Event Date 08/09/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device returned to supplier/manufacturer for evaluation and repair. The reported event is confirmed. Product was returned to the supplier for evaluation and repair. The visual inspection identified that the anodize appeared lighter than usual. It was alo noted that the hand piece runs forward but not in reverse. A lot of moisture was noted at the end of the motor and on top of the bearing. The appearance of the housing indicated that the anodize surface was coming off. The motor, housing, shaft face, threaded insert, tvs, housing, buttons, all seals, o-rings, and flex strip were replaced and tested per procedure. Maintenance review of the device indicates that it has not been previously repaired. Review of the complaint history determined that no further action is required. A definitive root cause was attributed to the moisture getting past the worn o-rings and seals, or the motor being worn from use, or both. No corrective actions, preventive actions, or field actions resulted after investigation of this event. 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
(b)(4). 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. The information provided on this form was previously submitted under manufacturing report number 0001825034-2017-08285.
 
Event Description
It was reported that at the beginning of an unknown procedure, this device did not work. The surgery was delayed for 50 minutes while exchanging the device with another one. The surgery was completed and no other adverse events have been reported at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6999221
MDR Text Key192793324
Report Number0001825034-2017-09692
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
Type of Report Initial,Followup
Report Date 03/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number906063
Device Lot NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2015
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

Patient Treatment Data
Date Received: 11/03/2017 Patient Sequence Number: 1
-
-