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

Catalog Number 00223200418

Device Problem Break (1069)

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

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It is reported that while the surgeon was applying tension to the cable, the cable broke.

Manufacturer Narrative

The returned product was confirmed to be fractured.The cable is frayed and fractured completely in two.The product was measured against the print specifications at several dimensions and it was confirmed that all measurements taken were within specification.The device history records were reviewed and the records indicated that the parts met specifications at the time of manufacture.A complaint history search found that this is the first report of any nature for this lot number.The cable is used for treatment.There is a package insert included with this instrument which has instructions for use.Some of the relevant instructions included in this insert are "the amount of tension placed on the cable surgically depends upon the clinical situation and requires judgment by the surgeon.Utmost care should be taken to prevent excessive tensioning of the cable around the bone because overtensioning may damage the bone.And, breakage of the cable may occur by overtensioning when the scale blade reaches full travel, leaving bundles of frayed cable inside the tensioner." due to the condition of the returned cable being frayed and fractured, the most likely cause of the cable breaking is overtensioning.

• 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: 5117579
• MDR Text Key: 27570191
• Report Number: 1822565-2015-02021
• Device Sequence Number: 1
• Product Code: HHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Followup
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00223200418
• Device Lot Number: 63034382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• 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