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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL TIBIAL NAIL CAP TRAUMA PROSTHESIS

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ZIMMER, INC. ZIMMER NATURAL NAIL TIBIAL NAIL CAP TRAUMA PROSTHESIS Back to Search Results
Catalog Number 47248700500
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)
Event Date 06/04/2016
Event Type  Injury  
Manufacturer Narrative
This report will be amended when our investigation is complete. Received, but not yet evaluated.
 
Event Description
It is reported that the patient was revised due to infection. While removing screws and a rod, the surgeon found a metal shaving in the tibial intramedullary canal.
 
Manufacturer Narrative
The device history records provided for this complaint were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified. Dimensions taken are within specifications. The returned tibial nail exhibits stripped internal threads, damage is too severe for accurate thread gauging. Shavings of the threads within the tibial nail cap are exhibited, along with a detached example of the thread shavings. Other returned components exhibit minimal wear or damage. The devices are used for treatment. Initial product history search revealed no additional complaints against the related part and lot combinations. The likely root cause of the metal shaving reported was cross threading on the internal threads of the nail cap. Single-use, sterilized devices manufactured or distributed by zimmer are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1. 0 x 10-6 or better. The root cause of the reported infection cannot be determined.
 
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Brand NameZIMMER NATURAL NAIL TIBIAL NAIL CAP
Type of DeviceTRAUMA PROSTHESIS
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
carrie schneider
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5829290
MDR Text Key50646187
Report Number0001822565-2016-02585
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/23/2015
Device Catalogue Number47248700500
Device Lot Number63082960
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/28/2016 Patient Sequence Number: 1
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