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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NATURAL NAIL TEAR DROP GUIDE WIRE ROD, FIXATION

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ZIMMER BIOMET, INC. NATURAL NAIL TEAR DROP GUIDE WIRE ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 05/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Concomitant medical products: catalog #: 47249009700, natural nail tear drop guide wire, lot # 63983829. (b)(6). 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.
 
Event Description
It was reported that there was a crease in the sealing area of the package.
 
Event Description
No further event information available at the time of this report.
 
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.
 
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Brand NameNATURAL NAIL TEAR DROP GUIDE WIRE
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7611767
MDR Text Key111441066
Report Number0001822565-2018-03316
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
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 Number63983832
Other Device ID Number(01) 00889024094789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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