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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 INSTRUMENT, TRAUMA
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ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER INSTRUMENT, TRAUMA 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.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. The following sections were updated: corrected: item number 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 NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER
Type of DeviceINSTRUMENT, TRAUMA
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 Key8028771
MDR Text Key125819597
Report Number0001822565-2018-06029
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
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,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
0 Patients were 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
Device Catalogue Number47249009700
Device Lot Number64021728
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2018
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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