MAUDE Adverse Event Report: OSSUR HF RE-FLEX SHOCK; PROSTHETIC FOOT

Model Number SSPE9300

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Field safety notice was sent to the customer in (b)(6) 2015, after the device was sent out to the user (2014).The field safety notice explicitly indicates non-össur componentry not to be fitted with the össur devices and to torque to appropriate settings.Furthermore, the ifu explicitly indicates recommends use of össur adapters.No indication of manufacturing failure was detected on the product during the analysis.(b)(4).

Event Description

The pyramid detached from the foot as the patient was walking.Patient fell and sustained injuries to the shoulder and wrist.

• Brand Name: RE-FLEX SHOCK
• 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: 8517658
• MDR Text Key: 142039848
• Report Number: 3003764610-2019-00006
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SSPE9300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/27/2018
• 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