MAUDE Adverse Event Report: DJO, LLC DONJOY DEFIANCE III FP; JOINT, KNEE, EXTERNAL BRACE

Model Number CONV DEFIANCE III FP

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

Patient Problem Injury (2348)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the patient "was in a 7 on 7 football scrimmage playing the position of tight end while wearing the brace, went out for a pass and upon changing direction planted on his right leg to come back to the ball he felt a pop and dropped to the ground." [sic] no further information is currently available.

Manufacturer Narrative

G1,2: updated to reflect new manufacturer point of contact.H3, h6: device was returned and evaluation was performed.According to the device evaluation the brace was in good condition and was functional.Per the condition, functionality, and manufacturing form the brace is built within specifications.No issues were found.

• Brand Name: DONJOY DEFIANCE III FP
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 9039229
• MDR Text Key: 161183870
• Report Number: 3012446970-2019-00030
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

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: Lay User/Patient
• Device Model Number: CONV DEFIANCE III FP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 08/21/2019
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention