MAUDE Adverse Event Report: ZIMMER INC COONRAD/MORREY PIN/BUSHING KIT; JDC

Catalog Number 32810502701

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/14/2016

Event Type  Injury  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to a broken locking pin.

Manufacturer Narrative

The provided photos show an inner pin that has fractured at its tines.However no devices were returned.Review of the device history records did not find any deviations or anomalies.The devices were used for treatment.No other complaints of any type have been reported for this lot of bushing kits.In the coonrad/ morrey total elbow revision surgical technique it states that, ¿if the size of the previous implant is unknown or uncertain at the time of operation, the humeral yoke gauge may be used intra-operatively to determine the size of implant.This instrument will confirm or determine the size of the well-fixed humeral implant in a patient needing revision or replacement.Once the size is determined, refer to the replacement/revision chart to choose the correct bushing kit for the proper humeral/ulna connection.¿ given that the patient was implanted with a small humerus and an extra small ulna a replacement bushing kit should have been selected per the replacement/revision chart.However a replacement kit was implanted.The subcomponents of the kit are smaller than those in the kit.This incompatible combination would expose the components to greater than anticipated forces, resulting in the reported failure.

• Brand Name: COONRAD/MORREY PIN/BUSHING KIT
• Type of Device: JDC
• 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: 5419647
• MDR Text Key: 37780631
• Report Number: 1822565-2016-00265
• Device Sequence Number: 1
• Product Code: JDC
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 32810502701
• Device Lot Number: 62644309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR