MAUDE Adverse Event Report: OSSUR SYMBIONIC LEG 3; ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT

Model Number SBL130010

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2014

Event Type  malfunction  

Event Description

Above knee amputee patient was walking with 10 pound package and stumbled as a result of loss of resistance in symbionic leg.Patient was not injured.

Manufacturer Narrative

Mdr decision based on failure analysis completed 01/09/2015.The angle sensor connector had corrosion damages so the signal from the angle sensor was interrupted/inconsistent.When the knee loses the signal or gets a signal that is out of range, the unit can lose resistance and will give out a warning.The knee is not designed for an environment where humidity would condense, see in the ifu.No injury has been reported, occurrence is low, 12 occurrences of this failure mode with only 1 single incident.No field safety corrective action will be executed.However this will be monitored closely and a capa has been initiated see in the corrective action part.

• Brand Name: SYMBIONIC LEG 3
• Type of Device: ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXT
• Manufacturer (Section D): OSSUR; reykjavik ; IC
• Manufacturer Contact: karen montes ; 27051 towne centre dr.; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 4428341
• MDR Text Key: 5283336
• Report Number: 3003764610-2015-00001
• Device Sequence Number: 1
• Product Code: ISW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SBL130010
• Device Catalogue Number: SBL130010
• Device Lot Number: 730176
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 84