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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH; ROD, FIXATION
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ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH; ROD, FIXATION Back to Search Results
Catalog Number 47249009800
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 09/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05729, 0001822565-2018-05734, 0001822565-2018-05744, 0001822565-2018-05745, 0001822565-2018-05746, 0001822565-2018-05747, 0001822565-2018-05749, 0001822565-2018-05750, 0001822565-2018-05751, 0001822565-2018-05754, 0001822565-2018-05755, 0001822565-2018-05756, 0001822565-2018-05757, 0001822565-2018-05758, 0001822565-2018-05752, 0001822565-2018-05748.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.Product not returned.
 
Event Description
It was reported that there was package defect with the seal peeled off.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the 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.
 
Event Description
No further event information available at the time of this report.
 
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Brand Name
TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH
Type of Device
ROD, 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 Key7969982
MDR Text Key123852383
Report Number0001822565-2018-05746
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 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2023
Device Catalogue Number47249009800
Device Lot Number64077372
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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