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

Catalog Number 00430900200

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As returned the threaded pin is seized in the humeral cut guide.Dimensional analysis of the guide found the remaining holes conforming.Dimensional analysis of the pin also found it conforming where measured.Additionally, galling and wear can be seen on the portion of the pin protruding from the guide.Review of the receiving inspection documents for the guide did not find any deviations or anomalies.The devices are used for treatment.Based on its lot number, the guide has an approximate field age of 7 years, 6 months.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 instructions for the guide states "where instruments form part of a larger assembly, check that the devices assemble readily with mating components.If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for a replacement." the previously accrued damage can most likely be attributed to normal wear and tear.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.

Event Description

It is reported that, during positioning of the humeral head cutting guide, the holding pin seized inside the instrument.

• Brand Name: TM HUMERAL CUTTING GUIDE
• Type of Device: KWT
• Manufacturer (Section D): ZIMMER INC; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5566171
• MDR Text Key: 42495435
• Report Number: 1822565-2016-01075
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/07/2015

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: 00430900200
• Device Lot Number: 60557911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2006
• 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