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U.S. Department of Health and Human Services

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

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ZIMMER, INC. COONRAD/MORREY PIN/BUSHING KIT ELBOW PROSTHESIS Back to Search Results
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).
 
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Brand NameCOONRAD/MORREY PIN/BUSHING KIT
Type of DeviceELBOW 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 Key5716680
MDR Text Key47125339
Report Number0001822565-2016-01993
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK001989
Number of Events Reported1
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 Received06/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number32810502701
Device Lot Number62811341
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 Received02/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-2752-2016

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