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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 70 CM LENGTH ROD, FIXATION

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ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH ROD, FIXATION Back to Search Results
Catalog Number 47249009800
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. 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. Product not returned.
 
Event Description
It was reported that there was a foreign material in the package. No patient involvement.
 
Manufacturer Narrative
Udi: (b)(4). Report source foreign - (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
No further event information available at the time of this report.
 
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Brand NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER 70 CM LENGTH
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7595584
MDR Text Key110858198
Report Number0001822565-2018-03149
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 company representative,distri
Type of Report Initial,Followup
Report Date 05/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Medical Equipment Company Technician/Representative
Device Catalogue Number47249009800
Device Lot Number63978650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No

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