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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER TEAR DROP GUIDE WIRE KNEE INSTRUMENT

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ZIMMER BIOMET, INC. ZIMMER TEAR DROP GUIDE WIRE KNEE INSTRUMENT Back to Search Results
Model Number N/A
Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 03/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). Reporter had indicated that product will be returned. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that foreign substances were inside of the sterile packages. No adverse events have been reported as a result of the malfunction.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was confirmed. The tear drop guide wire with its packaging is returned and from the returned product analysis it was determined that two small particles were found in one end of outer pouch seal area and this particulate matter is found to be acceptable per packaging criteria. Device history record was reviewed and no discrepancies were found. As package found to be within specification, no further corrective, preventive or field actions have resulted after the investigation of this event. 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 NameZIMMER TEAR DROP GUIDE WIRE
Type of DeviceKNEE INSTRUMENT
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7383821
MDR Text Key104028791
Report Number0001822565-2018-01911
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 distributor,foreign
Type of Report Initial,Followup,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47249009700
Device Lot Number63880351
Other Device ID Number(01)00689024094789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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