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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS ROD, FIXATION

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ZIMMER, INC. ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS ROD, FIXATION Back to Search Results
Catalog Number 47249009800
Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The product was not able to be evaluated, therefore, the complaint cannot be confirmed. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. 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
(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. (b)(4).
 
Event Description
It was reported during incoming inspection it was discovered the sterile barrier had a crease in the sealing area. No patient involvement. No adverse events have been reported as a result of the malfunction.
 
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Brand NameZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6591405
MDR Text Key194232615
Report Number0001822565-2017-03552
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Catalogue Number47249009800
Device Lot Number63545210
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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