MAUDE Adverse Event Report: ZIMMER INC TM HUMERAL CUTTING GUIDE; KWT

Catalog Number 00430900100

Device Problem Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 02/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The threaded pin and guide were returned for evaluation.Visual inspection confirmed that the 3.2 mm threaded pin is seized in the tm humeral cut guide.The other guide fixation holes were dimensionally inspected and one of the holes is undersized due to positives and burrs.The threaded pin exhibits damage to its tip and shaft.The devices were used for treatment.It is possible that damage to the guide and/or the pin was accrued during previous use and this damage caused interference between the two.This interference could have generated particulates that became trapped between the pin and the guide, thus potentially causing friction and eventually device seizure.The damage can most likely be attributed to normal wear and tear.Based on its lot number the guide has an approximate field age of 1 year and 2 months.No other complaints of any type have been reported for these lots of guide or pin.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 the threaded pin became stuck in the humeral cutting guide pin hole during use.Surgery was completed with another device.

• Brand Name: TM HUMERAL CUTTING GUIDE
• Type of Device: KWT
• 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: 5572228
• MDR Text Key: 42977551
• Report Number: 1822565-2016-01195
• 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: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00430900100
• Device Lot Number: 62254092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2013
• 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