MAUDE Adverse Event Report: OSSUR HF FLEX-RUN WITH NIKE SOLE; PROSTHETIC FOOT

Model Number FSX0087LO

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No fall/incident nor injury occurred due to the reported failure.Given the intended use (running, sports activities) of the product, there is a risk for issue leading to injury when failure would occur during use.Therefore we send in this vigilance report.Ossur is however not aware that the described failure type for this prosthetic foot ever led to injury.(b)(4).

Event Description

Device broke suddenly during training.No injuries occured.

• Brand Name: FLEX-RUN WITH NIKE SOLE
• Type of Device: PROSTHETIC FOOT
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 8621621
• MDR Text Key: 145529626
• Report Number: 3003764610-2019-00007
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FSX0087LO
• Device Catalogue Number: FSX0087LO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 90