MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER ZDR LOCKING SCREW; TRAUMA PROSTHESIS

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Information was received from a foreign source who is not required to complete form 3500a.(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the surgeon experienced a problem in extracting the zdr screw during surgery.

Manufacturer Narrative

This complaint was submitted when the surgeon experienced a problem in extracting the zdr screw during a surgery.No further information was provided with the complaint.No product was returned and no lot numbers were provided in relation to this complaint.Therefore, device history record review cannot be completed.There is not enough information to determine the exact cause of failure.This is the only complaint of this nature for the zdr system.This device is used for treatment.

• Brand Name: UNKNOWN ZIMMER ZDR LOCKING SCREW
• 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: 5285271
• MDR Text Key: 33483824
• Report Number: 1822565-2015-02616
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1