MAUDE Adverse Event Report: DJO LLC SHRT ARM FRACTURE BRACE, OPEN THUMB, BLK, LT, SM; ORTHOSIS, LIMB BRACE

Model Number 312-41-1111

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Nerve Damage (1979)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the exos brace allegedly tightened by itself over several days causing bruising and ulnar nerve damage.Communications between a djo quality team member and the patient on the phone, the patient stated that she noticed while in a warmer environment (80 - 90 degrees) such as the bathroom, when shower was running, is when she noticed in tightening "on it's own".She stated she removes the brace when she showers.The patient's re-application of the brace is controlled by her on how tight the boa strings are pulled.The ifu states the following: "wearing care should be taken with patients with delicate or compromised skin, especially the elderly, not to apply the brace too tightly, which may cause pressure and shear to the fragile tissue.Patients should be instructed on appropriate tensioning during ongoing use.If patient experiences any pain, swelling, sensation changes, or any unusual reactions while using this product, consult a healthcare professional immediately." the ifu also contains instructions on how to operate the boa(r) lacing and release tab system.The ifu states, "retighten the brace.Exos® braces are meant to be worn under light pressure and not tight to the skin.A little wiggle room inside an exos® brace promotes air circulation and helps maintain healthy dry skin.An over-tightened brace creates "shear" or pressure on the skin during motion, and can result in irritation, rash, odor, or skin issues.Wearing the brace too loose will reduce support and may compromise healing." additional reporting on this event will be provided as a supplemental report to this document if any further information becomes available.

Event Description

It was reported that the exos brace allegedly tightened by itself over several days causing bruising and ulnar nerve damage.

• Brand Name: SHRT ARM FRACTURE BRACE, OPEN THUMB, BLK, LT, SM
• Type of Device: ORTHOSIS, LIMB BRACE
• Manufacturer (Section D): DJO LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el flirdo; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: jim pomeroy ; 1430 decision street; vista, CA 92081 ; 5128346301
• MDR Report Key: 12096598
• MDR Text Key: 259347994
• Report Number: 9616086-2021-00011
• Device Sequence Number: 1
• Product Code: IQI
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 312-41-1111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other