MAUDE Adverse Event Report: ZIMMER, TURPEAUX INDUSTRIAL PARK BIPOLAR METAL SHELL

Catalog Number 00500104600

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2015

Event Type  malfunction  

Event Description

It is reported that the bipolar shell was missing the locking ring.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: BIPOLAR METAL SHELL
• Manufacturer (Section D): ZIMMER, TURPEAUX INDUSTRIAL PARK; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4603071
• MDR Text Key: 5469389
• Report Number: 2648920-2015-00070
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2015

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 Catalogue Number: 00500104600
• Device Lot Number: 62766046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2014
• 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