MAUDE Adverse Event Report: DJO LLC MAXTRAX 2.0, AIR, TALL, M; ORTHOSIS, CORRECTIVE SHOE

Model Number	79-95725
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that allegedly 3 patients developed skin breakdown needing wound care with one needing a skin graft and one borderline anterior tibial tendon exposure, though not infected.The devices are scheduled to be returned for evaluation, enovis will provide a supplemental when investigations are completed.
Event or Problem Description
It was reported that allegedly 3 patients developed skin breakdown needing wound care with one needing a skin graft and one borderline anterior tibial tendon exposure, though not infected.

• Brand Name: MAXTRAX 2.0, AIR, TALL, M
• Common Device Name: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 15396743
• Report Number: 9616086-2022-00024
• Device Sequence Number: 6463916
• Product Code: KNP
• UDI-Device Identifier: 00190446665939
• UDI-Public: 00190446665939
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: 79-95725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown