MAUDE Adverse Event Report: DJO, LLC DONJOY FULLFORCE,ACL,SHRT CF,RT,XS; JOINT, KNEE, EXTERNAL BRACE

Model Number 11-3220-1

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

Patient Problem Damage to Ligament(s) (1952)

Event Date 01/14/2020

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 "while she was wearing her brace, she was running a pass on one of her events, the double mini-trampoline.As she was exiting the trampoline, she was doing a full twist in the air.When she landed, her body was still in rotation when her feet planted on the mat.That was when she heard the pop of her right knee.Even with her brace on, she still managed to tear her acl (anterior cruciate ligament) graft in half.Surgery date is set for (b)(6) 2020." no further information is currently available.

Manufacturer Narrative

H3, h6: one fullforce,acl,shrt cf,rt,xs was returned for evaluation.Visual inspection was revealed no damage to the structure or components.The brace appears to have been used.The flexion is good, the problem reported by the customer could not be confirmed.A trend has not been identified.Complaint data for similar products and issues going back six months has been reviewed.The data indicates that customer complaints are within control.

• Brand Name: DONJOY FULLFORCE,ACL,SHRT CF,RT,XS
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• MDR Report Key: 9711294
• MDR Text Key: 179432134
• Report Number: 9616086-2020-00008
• 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: 02/13/2020

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: Health Professional
• Device Model Number: 11-3220-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention