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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 ROD, FIXATION

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ZIMMER BIOMET, INC. TEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Reported event was considered to be confirmed as visual evaluation of the four returned 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. Root cause was determined to be a manufacturing issue as the likely condition of the parts when they left zimmer biomet control is considered non-conforming based on the evaluation of the returned product. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03314, 0001822565-2018-03316, 0001822565-2019-00789, 0001822565-2019-00793.
 
Event Description
It was reported that there was a crease in the sealing area of the package.
 
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Brand NameTEAR DROP GUIDE WIRE 3.0 MM DIAMETER 100 CM LENGTH
Type of DeviceROD, FIXATION
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 Key8361572
MDR Text Key136860859
Report Number0001822565-2019-00793
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,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2019
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 Number63983829
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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