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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZNN TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH ROD, FIXATION

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ZIMMER BIOMET, INC. ZNN TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 07/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. (b)(4). (b)(6). Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 04573, 0001822565 - 2018 - 04574, 0001822565 - 2018 - 04575, 0001822565 - 2018 - 04576.
 
Event Description
It was reported that upon incoming inspection at the warehouse, it was discovered that there was staining found on the product. No adverse events occurred, as there was no patient involvement. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that the reported device did not cause or contribute to the event.
 
Event Description
No further event information available at the time of this report.
 
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Brand NameZNN TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH
Type of DeviceROD, FIXATION
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 Key7803091
MDR Text Key117835956
Report Number0001822565-2018-04572
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47249009800
Device Lot Number64048686
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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