MAUDE Adverse Event Report: INTEGRUM AB AXOR II

Model Number 1288

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 06/17/2021

Event Type  malfunction  

Event Description

Integrum (b)(4) was informed on 07/08/2021 that the patient had fallen and broken his prosthetic foot (not manufactured by integrum).During the incident, the release function of the axor ii was not initiated (the unit did not release in bending or rotation).After the incident, there is sound in the axor ii unit, primarily when walking on an inclined surface, like there is a "slam" in it after the fall.The date of the incident is unknown.The unit was sent to integrum for technical investigation and repair.During investigation, the clicking sound could not be replicated, however the top body was found to be worn and the bending punch to be damaged.During service, top body and bending punch were replaced.Integrum has recommended to inspect the other prosthetic components that could be damaged and cause clicking after the fall.Further, integrum has requested additional information from the patient regarding the fall, to be able to understand if the axor ii should have released or not (i.E.If there was a malfunction or not).

Event Description

Integrum ab was informed on (b)(6) 2021 that the patient had fallen and broken his prosthetic foot (not manufactured by integrum).During the incident, the release function of the axor ii was not initiated (the unit did not release in bending or rotation).After the incident, there is sound in the axor ii unit, primarily when walking on an inclined surface, like there is a "slam" in it after the fall.The unit was sent to integrum for technical investigation and repair.During investigation, the clicking sound could not be replicated, however the top body was found to be worn and the bending punch to be damaged.During service, top body and bending punch were replaced.Integrum has recommended to inspect the other prosthetic components that could be damaged and cause clicking after the fall.Further, integrum has requested additional information from the patient regarding the fall, to be able to understand if the axor ii should have released or not (i.E.If there was a malfunction or not).08/16/2021: integrum received additional information from the patient regarding the fall.According to the patient, the foot had come off from the prosthesis (not manufactured by integrum) which caused the patient to fall down forward with an extended knee.The axor ii is intended to release when a bending moment of more than 70 nm is applied in the walking direction.Since during the fall the knee was in the extended position, the axor ii was not subjected to any bending forces.Therefore there was no reason for the unit to release, and the unit is therefore considered to function as intended.

• Brand Name: AXOR II
• Type of Device: AXOR II
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12172981
• MDR Text Key: 261695521
• Report Number: 3011386779-2021-00057
• Device Sequence Number: 1
• Product Code: PJY
• UDI-Device Identifier: 07340152100634
• UDI-Public: 07340152100634
• Combination Product (y/n): N
• PMA/PMN Number: P190009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1288
• Device Catalogue Number: 1288
• Device Lot Number: 91292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Date Manufacturer Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other