MAUDE Adverse Event Report: ZIMMER, INC. CABLE-READY CABLE PIN SYSTEM WITH TWO CABLE AND PIN ASSEMBLY; TRAUMA PROSTHESIS

Model Number N/A

Device Problem Material Frayed (1262)

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

Event Date 05/18/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the end of one of the cables had a small fray.Another cable was opened and used to complete the surgery.

Manufacturer Narrative

Device history records were reviewed with no deviations or anomalies identified that would have contributed to the reported event.The cable was not returned for review, so current condition of the device cannot be confirmed.This device is used for treatment.An initial product history search conducted (b)(6) 2016 revealed no additional complaints against the related part and lot combinations.It was reported that the fraying may have occurred when the cable was being put through the driver, but this cannot be confirmed.The zimmer cable-ready cable pin system abbreviated surgical technique indicates that the cable is threaded through the cable pin driver until the hex of the pin at the cable-pin junction is locked into the driver tip.The exact driver that was used and the condition of the driver are unknown.A definitive root cause for the fraying cannot be determined with the information provided.

• Brand Name: CABLE-READY CABLE PIN SYSTEM WITH TWO CABLE AND PIN ASSEMBLY
• 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: 5729949
• MDR Text Key: 47544973
• Report Number: 0001822565-2016-02082
• Device Sequence Number: 1
• Product Code: JDQ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

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 Model Number: N/A
• Device Catalogue Number: 00223205018
• Device Lot Number: 63185796
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2015
• 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