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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 Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2018
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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03395, 0001822565-2018-03394, 0001822565-2018-03393, 0001822565-2018-03392, 0001822565-2018-03391, 0001822565-2018-03390, 0001822565-2018-03389.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.Product not returned.
 
Event Description
It was reported that the products had stains within the sterile barrier.This was found at the distributorship and not during a procedure.There was no patient involvement.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Report source foreign ¿ (b)(6).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned products identified the returned product's packaging did have a stain on the packaging.Device history record was reviewed and no discrepancies were found.The root cause of the reported issue is attributed to a manufacturing deficiency.Complaints are being monitored and reviewed.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.
 
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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 Key7629410
MDR Text Key112050374
Report Number0001822565-2018-03390
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PK101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Catalogue Number47249009700
Device Lot Number64000511
Other Device ID Number(01)00889024094789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/28/2018
Initial Date FDA Received06/22/2018
Supplement Dates Manufacturer Received05/02/2019
Supplement Dates FDA Received05/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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