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

Model Number 01EP-L

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 03/27/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that a patient walkers' frames broke and allegedly a surgical fixation screw within the patient's ankle became loose.The device has not been returned to djo.If the device is returned, the investigation will be submitted with a supplemental filing.

Event Description

It was reported that a patient walkers' frames broke and allegedly a surgical fixation screw within the patient's ankle became loose.

• Brand Name: AIRSELECT, ELITE,
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• 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: 11740344
• MDR Text Key: 250200216
• Report Number: 9616086-2021-00006
• 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
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 01EP-L
• Device Lot Number: N/A
• Date Manufacturer Received: 03/29/2021
• 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