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

Catalog Number FSX0086HI

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Fall (1848); Concussion (2192)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

Product failed to provide support when carbon blade broke by brittle failure when user (sport athlete) was sprinting at approx 20 mph, causing him to fall.The user is a sports athlete with impact level extreme and activity level very high.He sustained a concussion and was off training for a week.

• 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: 11054853
• MDR Text Key: 239205734
• Report Number: 3003764610-2020-00002
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: FSX0086HI
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/03/2020
• 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 Outcome(s): Other
• Patient Age: 42 YR
• Patient Weight: 75