MAUDE Adverse Event Report: DJO, LLC DONJOY; DEFIANCE FP

Model Number CONV DEFIANCE FP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Damage to Ligament(s) (1952)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Complaint received that alleges "re-tore her knee while in the brace.She jumped over the girl's foot.When she landed the brace was locked in a straight position instead of bent.Causing the injury.When she took the brace off, when we examined it to see why it wouldn't bend, a screw and another small piece fell out".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.

• Brand Name: DONJOY
• Type of Device: DEFIANCE FP
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJO, LLC; 3151 scott street; vista CA 92081 9663
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 6419496
• MDR Text Key: 70406364
• Report Number: 2020737-2017-00001
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CONV DEFIANCE FP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other