MAUDE Adverse Event Report: DJO LLC AIRSELECT, ELITE; ORTHOSIS, CORRECTIVE SHOE

Model Number 01EP-XL

Device Problem Break (1069)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

It was reported that the patient walkers' buckle broke and the patient allegedly reinjured their achilles tendon.

Manufacturer Narrative

It was reported that the patient walkers' buckle broke and the patient allegedly reinjured their achilles tendon.The device has not been returned to djo.If the device is returned, the investigation will be submitted with a supplemental filing.

Manufacturer Narrative

The product was returned to djo and evaluated.The evaluation conclusion is the product was used, the top strap has a metal buckle and different seams, the hooks of the calf liner were also modified, the evidence of the broken buckle was not obtained, it was not possible to confirm the issue reported by the customer.The unit was found to be manufactured correctly.

• Brand Name: AIRSELECT, ELITE
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; suite 200; carlsbad CA 92010
• 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 ; 5919 sea otter place; suite 200; carlsbad, CA 92010 ; 5128346301
• MDR Report Key: 13054395
• MDR Text Key: 284617903
• Report Number: 9616086-2021-00018
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 01EP-XL
• Device Lot Number: G-417087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male