MAUDE Adverse Event Report: ZIMMER INC UNKNOWN 3.5 MM CORTICAL SCREW; TRAUMA IMPLANT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Information was received from a health professional 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 that when the surgeon uses 3.5mm cortical screws for applications with hard cortical bone, the screw head occasionally strips as the screw is tightened.

Manufacturer Narrative

Screw heads of 3.5 mm cortical screws were reported to strip during plating of a fracture.There was no resulting delay in surgery.No physical product or photographs are available for evaluation.The device was used for treatment.Device history records and inspection reports cannot be reviewed since the lot numbers are unknown.Definitive root cause cannot be determined with the information provided.The devices are used for treatment.

• Brand Name: UNKNOWN 3.5 MM CORTICAL SCREW
• Type of Device: TRAUMA IMPLANT
• 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: 5344875
• MDR Text Key: 35349835
• Report Number: 1822565-2016-00008
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/08/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• 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
• Patient Sequence Number: 1