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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER INC ZIMMER TRABECULAR METAL TOTAL ANKLE PIN HSN

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ZIMMER INC ZIMMER TRABECULAR METAL TOTAL ANKLE PIN HSN Back to Search Results
Catalog Number 00450104004
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This report will be amended when our investigation is complete.
 
Event Description
It is reported inner plastic wrapping was damaged; therefore, the sterility could not be confirmed.
 
Manufacturer Narrative
A self drilling pin with packaging contents was returned for review. As returned, the wrap-around label was broken. The tamper proof label was intact. The outer tyvek lid was partially removed. The inner tyvek lid is partially delaminated and attached to the outer lid. The peel tab was sealed between the outer tyvek lid and cavity. This device is used for treatment. No other complaints of this nature have been reported for the part number involved. A stock investigation was attempted for the part/lot combination and no inventory was available to investigate. The lot has been fully distributed with no further reported complaints of this nature. The packaging inspection procedure includes both tyvek/cavity and 100% visual inspections to prevent the reoccurrence of this issue. Root cause has been determined to be a packaging deficiency.
 
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Brand NameZIMMER TRABECULAR METAL TOTAL ANKLE PIN
Type of DeviceHSN
Manufacturer (Section D)
ZIMMER INC
p.o. box 708
warsaw IN 46581 0708
Manufacturer Contact
kevin escapule
p.o. box 708
warsaw, IN 46581-0708
8006136131
MDR Report Key5398572
MDR Text Key37139106
Report Number1822565-2016-00159
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00450104004
Device Lot Number63147328
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2015
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

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