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

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.

• Brand Name: ZIMMER TRABECULAR METAL TOTAL ANKLE PIN
• Type of Device: HSN
• 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 Key: 5398572
• MDR Text Key: 37139106
• Report Number: 1822565-2016-00159
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00450104004
• Device Lot Number: 63147328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1