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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 TRAUMA, INSTRUMENT

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ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER TRAUMA, INSTRUMENT Back to Search Results
Catalog Number 47249009800
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). Complaint sample was evaluated and the reported event was confirmed. Evaluation of the returned products confirmed that the packaging for both products contained loose particles of blue in color. Device history record was reviewed and no discrepancies were found. The likely condition of the product when they left zimmer biomet control is considered non-conforming based on the evaluation of the returned products. A manufacturing deficiency is considered to be the root cause of the reported issue. Event is being reviewed through the capa process. 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 a foreign material in the package. No patient involvement.
 
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Brand NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER
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 Key8592677
MDR Text Key144480626
Report Number0001822565-2019-01813
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 05/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number47249009800
Device Lot Number63978650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2018
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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