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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL SYSTEM - TEAR DROP GUIDE WIRE ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). 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. Expected, not yet received.
 
Event Description
It was reported during incoming inspection at the warehouse, that it was discovered there was a crease in the sealing area. There was no patient involvement.
 
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed. Evaluation of the returned products found the seal to be within specifications. Since the seal was acceptable and there would be no risk to the sterility of the device, re-evaluation of this product to no longer be reportable for this event; the event is being reported on 0001822565-2018-06344. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
No additional information received.
 
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Brand NameZIMMER NATURAL NAIL SYSTEM - TEAR DROP GUIDE WIRE
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8067631
MDR Text Key127073128
Report Number0001822565-2018-06359
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2018
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 Number64048689
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

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