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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 100 CM LENGTH; TRAUMA, INSTRUMENT
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ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH; TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 47249009700
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 10/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05980, 0001822565-2018-05981, 0001822565-2018-05983, 0001822565-2018-05985, 0001822565-2018-05986, 0001822565-2018-05988, 0001822565-2018-05989, 0001822565-2018-05990, 0001822565-2018-05992, 0001822565-2018-05993, 0001822565-2018-05995, 0001822565-2018-05996, 0001822565-2018-05998, 0001822565-2018-05999, 0001822565-2018-06001, 0001822565-2018-06002, 0001822565-2018-06004, 0001822565-2018-06006, 0001822565-2018-06008, 0001822565-2018-06010, 0001822565-2018-06011, 0001822565-2018-06012, 0001822565-2018-06014, 0001822565-2018-06015.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 a crease was found in the sealing area during incoming inspection.There was no patient involvement.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Report source - foreign ¿ japan.Visual examination of the returned products identified that 13 pieces from lot # 64053676, 11 were found conforming and two pieces failed and 12 pieces from lot # 64021728 were found to be conforming.Device history record was reviewed and no discrepancies were found.There was no issue found with the product.The device evaluation found no malfunction and the event did not contribute to injury, therefore this would not be considered a reportable 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 100 CM LENGTH
Type of Device
TRAUMA, INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8027420
MDR Text Key125759040
Report Number0001822565-2018-06003
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Catalogue Number47249009700
Device Lot Number64053676
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2018
Was the Report Sent to FDA? No
Date Manufacturer Received07/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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