MAUDE Adverse Event Report: ZIMMER INC ZIMMER SELF-TAPPING BONE SCREW; MRA

Catalog Number 00625006530

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2013

Event Type  malfunction  

Manufacturer Narrative

The bone screw was returned with the outer tyvek lid completely removed from the outer cavity.Visual inspection concluded that the "peel" tab of the inner tyvek lid was sealed between the outer cavity and tyvek lid.When the outer lid was removed, the inner tyvek lid was delaminated.Investigation of the manufacturing process found this to be an operator error.The device was used for treatment.The inner lid stock has been erroneously sealed into the outer lid seam during packaging.Corrective and preventive actions were conducted to address the reported issue.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reported that when the delivery of the product was attempted onto the sterile field, it was unsuccessful due to the inner implant packaging adhering to the outer lid.

• Brand Name: ZIMMER SELF-TAPPING BONE SCREW
• Type of Device: MRA
• 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: 5572482
• MDR Text Key: 42494955
• Report Number: 1822565-2016-00911
• Device Sequence Number: 1
• Product Code: MRA
• 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: Other
• Type of Report: Initial
• Report Date: 10/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 00625006530
• Device Lot Number: 62444804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2013
• Initial Date FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2013
• 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