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

Lot Number 00223200418

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 09/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the patient was revised due to experiencing pain from a frayed cable.

Manufacturer Narrative

This report is being amended to reflect changes in sections.This report will be amended when our investigation is complete.

Manufacturer Narrative

The package insert states: "the cable-ready system components cannot be used in conjunction with any other cerclage or bone plate systems.Only instruments specifically designed for this cable system should be used during implantation." it also states: "failure to cut excess cable flush with the device at completion of the procedure may compromise the integrity of the system and lead to decrease in function or durability, or skin irritation." when the cables are used with a plate, buttons are indicated to be used to keep the cable from directly contacting the plate.A likely root cause for the alleged fraying of the cable end cannot be determined with the information provided.No product was returned with this complaint for review.It cannot be determined which of two possible lot numbers is the subject of the complaint.The device history records were reviewed for both possible lots.Review of the device history record indicates the devices were manufactured to specifications.

• Brand Name: CABLE READY CERCLAGE CABLE WITH CRIMP
• Type of Device: TRAUMA PROSTHESIS
• 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: 5264993
• MDR Text Key: 32629636
• Report Number: 1822565-2015-02512
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2015

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?: No
• Device Operator: Health Professional
• Device Lot Number: 00223200418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/04/2015; 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 75