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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. POWERTEK II PLUS SHAVER HANDPIECE ARTHROSCOPE Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 08/09/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. The device had a stall error and did not run without turning the drive lug by hand. One bad hall signal and a wide space were noted at the connector end of the hand piece. The threaded insert stuck to the motor retainer ring. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Investigation results concluded that the reported event was due to flattened o-rings and seals leading to a possible moisture breach reaching the motor inside the housing and a bad motor. 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
This follow-up report is being submitted to relay additional information.
 
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.
 
Manufacturer Narrative
(b)(4) part #:906063 lot:# 71624, part #:906063 lot:# 71569, part #:906063 lot:# 71574. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-08285, 0001825034-2017-08286, 0001825034-2017-08288.
 
Event Description
It was reported that during an unknown procedure, four devices created unknown malfunction. No adverse events have been reported as a result of the malfunction. Attempts have been made to gather information but no further information has been provided.
 
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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 Key6938276
MDR Text Key113931752
Report Number0001825034-2017-08284
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,Followup,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2017
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 Number71635
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 Received07/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2016
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: 10/10/2017 Patient Sequence Number: 1
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