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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: 0001822565-2018-05809, 0001822565-2018-06016, 0001822565-2018-06017, 0001822565-2018-06019, 0001822565-2018-06020, 0001822565-2018-06021, 0001822565-2018-06022, 0001822565-2018-06023, 0001822565-2018-06024, 0001822565-2018-06025, 0001822565-2018-06026, 0001822565-2018-06027, 0001822565-2018-06028, 0001822565-2018-06029, 0001822565-2018-06030, 0001822565-2018-06031.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 stain was found on the product during incoming inspection.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.The stains are caused by the way the tear drop guide wires are fixtured during passivation.The guide wires are placed on a rack with two or more contact points.These contact points cause a small portion of the guide wire to not receive a full passivation coating, leading to an inconsistent coating appearing as a "stain" or mark.These stains are not corrosion, and do not impact the fit, form, or function of the guidewires; they are merely cosmetic.The product is conforming per zimmer biomet's criteria.Device history record was reviewed and no discrepancies were found.The root cause is determined as no device issue identified.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 Key8028748
MDR Text Key125820907
Report Number0001822565-2018-06023
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 03/18/2019
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 Number64040387
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2018
Was the Report Sent to FDA? No
Date Manufacturer Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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