MAUDE Adverse Event Report: ZIMMER INC CABLE READY CABLE GRIP SYSTEM; JDQ

Catalog Number 00223200518

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A complaint history search found that this is the first complaint of this nature part number lot number combination.Due to the product not being returned, this complaint cannot be confirmed and no product issue was identified.This product will be monitored for any adverse complaint trends.There was no product returned; therefore, no physical evaluation could be conducted.All of the device history records were reviewed and the records indicated that the parts met specifications at the time of manufacture.The cable is used for treatment.

Event Description

It is reported the cable end was longer than normal and would not seat flush to the plate.

• Brand Name: CABLE READY CABLE GRIP SYSTEM
• Type of Device: JDQ
• 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: 5541246
• MDR Text Key: 41655846
• Report Number: 1822565-2016-00808
• 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: Other
• Type of Report: Initial
• Report Date: 03/04/2016

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: 00223200518
• Device Lot Number: 63019814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2015
• 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 Age: 68 YR