MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER BONE SCREW; HWC

Model Number N/A

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported a hair was in the sealed packaging of the device.

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, but not yet evaluated.

Manufacturer Narrative

As returned, a hair is confirmed to be present in the tyvek seal.No discrepancy was found during the dhr, and material information sheet (mis) evaluation regarding the operational process.Mis demonstrates that visual inspections were performed and documented accordingly to the applicable curriculum.No scraps were found during the manufacturing process of lot #62153285.This device is used for treatment.Based on the investigation results, the cause was attributed to the operator not following the procedures.The current packaging personnel were assessed on the procedures, and no discrepancy was found between operator execution and the procedures.Inspections instructions were improved and strengthened to avoid and capture nonconformities related to contaminated product (hair in the sterile package).Awareness was provided to disseminate the reported condition.No additional complaint was found related to same failure mode and product family of the reported device, therefore no further actions will be required.The root cause of the hair in the sterile package is that an operator did not follow the procedures.

• Brand Name: ZIMMER BONE SCREW
• Type of Device: HWC
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5646356
• MDR Text Key: 45121992
• Report Number: 0002648920-2016-00836
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00115001200
• Device Lot Number: 62153285
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2012
• 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