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

Catalog Number 00223200118

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

It is reported that upon opening the packaging, it was noticed that the screw was missing.A new implant was opened and used.

Manufacturer Narrative

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

Manufacturer Narrative

There was no impact to the patient, as the surgery was completed with another device with no delay.This device is used for treatment.The product was scrapped at the time of the event; therefore, no physical evaluation could be conducted.The device history records could not be reviewed due to lack of product identification.There are no other complaints of this nature for this lot number.Based complaints of this nature for this lot number.Based on information provided, a definitive root cause cannot be established.

• Brand Name: CABLE-READY CERCLAGE CABLE WITH CRIMP
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4780898
• MDR Text Key: 5859501
• Report Number: 1822565-2015-00700
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

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: 00223200118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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