MAUDE Adverse Event Report: ZIMMER, INC. CABLE-READY CERCLAGE CABLE WITH CRIMP; TRAUMA PROSTHESIS

Catalog Number 00223200118

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, not yet evaluated.

Event Description

It is reported that the set screw fell out of the cable assembly and was unable to be used to secure the cable.

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, but not yet evaluated.

Manufacturer Narrative

As returned the set screw was not assembled to the remainder of the cable.The hex head and the 1.8mm sleeve both had damage.Returned product was within specifications where measured, and optical comparator was used to measure the height of the screw.Functional testing found the returned screw was able to properly mate with the 1.8mm sleeve and not fall out when held upside down.Device history record review indicates all devices were manufactured to specifications.No deviations or anomalies were found that would contribute to the event described.The device is used for treatment.Initial product history search revealed no additional complaints against the related part and lot combination.As the screw was able to be re-assembled there is insufficient reason to suspect a manufacturing defect at this time.The likely root cause of the screw reportedly falling out during the procedure cannot be determined.

Manufacturer Narrative

This report is being amended to reflect changes.

• Brand Name: CABLE-READY CERCLAGE CABLE WITH CRIMP
• Type of Device: TRAUMA 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: 5776090
• MDR Text Key: 48983607
• Report Number: 0001822565-2016-02273
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00223200118
• Device Lot Number: 63185803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/25/2016; 09/24/2016; 10/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2015
• 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