MAUDE Adverse Event Report: ZIMMER INC BIGLIANI/FLATOW THUMB SCREW; KWT

Catalog Number 00430100201

Device Problems Fracture (1260); Material Integrity Problem (2978)

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

Event Date 09/03/2014

Event Type  malfunction  

Manufacturer Narrative

Information was received from a health professional who is not required to complete form 3500a.The thumb screw returned has fractured threads, the threads fractured off inside the humeral stem.The fractured piece remains in the stem where it was threaded into when it was fractured.The device was used for treatment.Though the lot number is unknown, there is an indicator the instrument was manufactured prior to september 2005 when a material change was made from 13-8 sst to 465 sst.The material change was made due to superior mechanical strength and ductility of 465 sst.The exact field age of the component is unknown, but due to the material composition noted, it has a minimum age of 9 years.This event can be considered related to a previously addressed design issue.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It was reporting that during arthroplasty procedure, after striking an implantable stem with a mallet and checking the instrument thumb screw for tightness between blows, the tip of the thumb screw broke off in the stem.

• Brand Name: BIGLIANI/FLATOW THUMB SCREW
• Type of Device: KWT
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5566508
• MDR Text Key: 42271570
• Report Number: 1822565-2016-01021
• Device Sequence Number: 1
• Product Code: KWT
• 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
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00430100201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR