MAUDE Adverse Event Report: ZIMMER INC BIGLIANI FLATOW HUMERAL STEM; HSD

Catalog Number 00430001417

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It was reported that when the implant was being opened, the surgeon noted the implant had punctured through both of the sterile packaging boxes.The implant was rejected and not used for surgery.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

A humeral stem and packaging content was returned for review.As received, the shrink wrap and end panel label are torn.The outer tyvek has been removed.The inner tyvek is still intact.The stem has punctured through the foam pouch and both the inner and outer cavities.The device was packaged in november 2007.Device history record review indicates the devices were manufactured to specifications.The packaging documentation shows all devices that were completed and sent to inventory met specifications.Device history records shows no anomalies or deviations that would have affected or contributed to the reported event.This device is used for treatment.Initial product history search conducted on (b)(4) 2016 revealed no additional complaints against the related part and lot combination.The iaf was opened to investigate this issue.The root cause is currently under investigation as part of a capa and has not been determined.

• Brand Name: BIGLIANI FLATOW HUMERAL STEM
• Type of Device: HSD
• 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: 5533816
• MDR Text Key: 41549685
• Report Number: 1822565-2016-00826
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 00430001417
• Device Lot Number: 60834744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR