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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 Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 09/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-05438, 0001822565-2019-00787, 0001822565-2019-00788, 0001822565-2019-00791, 0001822565-2019-00792, 0001822565-2019-00794, 0001822565-2019-00795, 0001822565-2019-00797, 0001822565-2019-00798, 0001822565-2019-00799, 0001822565-2019-00800. Complaint sample was evaluated and the reported event was confirmed. Evaluation of the eighteen (18) products returned identified only eleven (11) products confirmed the presence of crease and/or fold in the seal of the pouches. Device history record was reviewed and no discrepancies were found. Manufacturing deficiency is considered as the root cause of the reported issue and corrective action is being conducted. 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
It was reported that there was package defect. Seal had a crease in the sealing area.
 
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Brand NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH
Type of DeviceTRAUMA, INSTRUMENT
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 Key8357602
MDR Text Key136744581
Report Number0001822565-2019-00788
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number47249009700
Device Lot Number64091453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0542-2019

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