MAUDE Adverse Event Report: DJO LLC EXOS SAFB-OT; ORTHOSIS, LIMB BRACE

Model Number 312-41-1111

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Tears (2516)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the exos short arm fracture brace, open thumb, allegedly got under the cast and the skin healed over the wire.The physician had to lacerate the skin to remove the wire.The customer reported no damage was found to the brace the patient was wearing.There were no non-conforming material reports (ncmr) associated with the product that may have contributed the reported event.Customer complaint history of the reported device showed no present or previous trends or on-going issues.The root cause of this complaint is unknown.Possible root cause is patient maintenance or misapplication of the brace.There has been nor further reported incident with this patient.

Event Description

It was reported that the exos brace got under the cast and the skin healed over the wire.The physician had to lacerate the skin to remove the wire.

• Brand Name: EXOS SAFB-OT
• 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., MX 22 244; MX MX 22244
• Manufacturer Contact: jim pomeroy ; 1430 decision street; vista, CA 92081 ; 5128346301
• MDR Report Key: 11018975
• MDR Text Key: 221743223
• Report Number: 9616086-2020-00039
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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
• Device Catalogue Number: N/A
• Device Lot Number: NOT REPORTED
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention