MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. VERSA-FX STANDARD TUBE PLATE

Catalog Number 00119313003

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2014

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the compression plate would not connect to the lag screw.A different plate was used and connected immediately.

• Brand Name: VERSA-FX STANDARD TUBE PLATE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715 026
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715 026
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4254031
• MDR Text Key: 19047516
• Report Number: 2648920-2014-00311
• Device Sequence Number: 1
• Product Code: KTT
• 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: 10/15/2014

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: 09/30/2023
• Device Catalogue Number: 00119313003
• Device Lot Number: 62475748
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• 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