MAUDE Adverse Event Report: ZIMMER, INC. COONRAD/MORREY PIN/BUSHING KIT ELBOW PROSTHESIS

Catalog Number 32810502701

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the inner package was missing one bushing from the kit.

Manufacturer Narrative

Due to the reported event of 1 humeral bushing contained within the packaging, when 2 bushings are required for use, the decision was made to initiate field action. Recall z-2752-2016 was initiated on september 08, 2016, and necessary corrective and preventive actions are being investigated.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. A device history record review shows lot 62811341 is a 25 piece order. The assembly/traceability record indicates 25 bushings were issued and that only 25 pieces are required. Per the blue print, a total of 50 pieces should have been issued. As the kit was opened and used it was not returned for review. This device was used for treatment. The drawing for the device has listed quantity of 2 for the bushing. The quantity on the bill of material should list 50 as the standard quantity per the 2 required in the kit drawing, but instead states 25. The most likely cause of the incorrect quantity packed was an error in the bill of material. This report is number 1 of 2 mdrs filed for the same surgery (reference 0001822565-2016-02001).

• Brand Name: COONRAD/MORREY PIN/BUSHING KIT
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5716680
• MDR Text Key: 47125339
• Report Number: 0001822565-2016-01993
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 32810502701
• Device Lot Number: 62811341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2752-2016