MAUDE Adverse Event Report: INTEGRUM AB OPRA AXOR II

Model Number 1288

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 09/02/2021

Event Type  malfunction  

Event Description

Integrum has been informed that the axor ii unit on three occasions has fallen off (detached) from the abutment, causing the patient to fall.The patient was bruised but did not sustain any other injury.As soon as integrum learned about the incident, a loan unit was sent to exchange the patient unit, and the patient unit was sent to integrum for technical investigation.Technical investigation has been performed.Clamps found damaged.The damage on the clamps indicates that the abutment was not inserted till the bottom of the abutment before gripping.Not inserting the abutment till the bottom before gripping can affect the attachment function of the axor ii.Also unit was found unclean inside.The cleaning of the device has not been performed according to the ifu.Not cleaning the axor ii can cause failure of the product.Integrum has requested a video of the patient donning the device, to investigate if this is performed according to the ifu or if suboptimal donning could have contributed to the fall.

Event Description

Manufacturing investigation has been performed.Batch documentation reviewed (docreg 011 256-00).Unit was released with two concessions, but both concessions are regarding typos in batch documentation, i.E.They do not affect device safety or performance.The device has been manufactured according to specification.Technical investigation of the unit has been performed.Clamps found damaged.The damage on the clamps indicates that the abutment was not inserted till the bottom of the abutment before gripping it with the axor ii.Not inserting the abutment till the bottom before gripping can affect the attachment function of the axor ii.During service, the damaged clamps were replaced and the unit was cleaned.In order to assess if the patient performs donning of the device properly, integrum requested a video from the prosthetist, showing the patient donning the device and walking a few steps.This video indicated that there was an issue with the coupling of the axor ii and the prosthetic leg, as the prosthetic leg was seen to rotate together with the axor ii while tightening the grip.This suggested that the axor ii may not have been properly tightened, which could cause the unit to fall off.A call was taken between the responsible prosthetist, integrum sales rep and technical product manager, where the prosthetist was informed about the findings.During the call, it was highlighted the importance of the donning/doffing procedure.Furthermore, the prosthetist was informed that there is a rotation in the prosthesis that could affect the attachment function.The investigation concludes that the axor ii was not secured properly to the abutment, causing the issue with the unit falling off.The root cause is concluded to be use error.The responsible prosthetist was informed and instructed.

• Brand Name: OPRA AXOR II
• Type of Device: OPRA AXOR II
• Manufacturer (Section D): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer (Section G): INTEGRUM AB; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• Manufacturer Contact: sofie ludvigsson ; krokslatts fabriker 50; molndal, 43137 ; SW 43137
• MDR Report Key: 12639125
• MDR Text Key: 276683097
• Report Number: 3011386779-2021-00059
• Device Sequence Number: 1
• Product Code: PJY
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P190009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• 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: 56105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75 KG