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

Catalog Number 00223200228

Device Problem Break (1069)

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

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that during the tensioning of a trauma cable, the surgeon observed a partial breakage of the cable.

Manufacturer Narrative

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

Manufacturer Narrative

The cable was returned for review.Visual inspection confirms the reported fraying.Dimensions were found conforming to print specifications where measured.Device history records could not be reviewed as the lot number is unknown.This device is used for treatment.A product history search could not be performed as the lot number is unknown.It was indicated that the surgical technique was utilized for this product, therefore a definitive root cause cannot be determined.

• 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: 5885881
• MDR Text Key: 52419464
• Report Number: 0001822565-2016-02869
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 07/20/2016

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: 00223200228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/21/2016; 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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