MAUDE Adverse Event Report: ABILITY DYNAMICS LLC RUSH81; PROSTHETIC FOOT

Model Number 81

Device Problems Break (1069); Detachment Of Device Component (1104); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2014

Event Type  malfunction  

Event Description

Per (b)(6)'s prosthetist, on (b)(6) 2014 on a phone call conversation to ability dynamics, the following was reported: (b)(6) was at school and stopped to tie his shoe.When he arose and began to hurry to catch up with friends, his rush81 foot broke.When the last bolt broke, the upper portion of the bracket separated from the keel or upper composite piece.This left david with only a portion of the foot still attached to his prosthesis.David stumbled, but there was no report of him falling.There were no injuries, and to the best of our knowledge, (b)(6) did not see a physician.

Manufacturer Narrative

Email sent from (b)(4) (ability) (b)(4) 2014.Requested the return of the broken rush81 foot with all components.Told (b)(6) he would be informed of the outcome of the investigation.Told (b)(6), ability is sending replacement rush81 and rush87 feet to see which works best.Email sent from (b)(6) 2014.Received the feet and is calling in the patient.Email sent to (b)(6) 2014: (b)(4) confirmed this was covered by warranty.(b)(4) told (b)(6) there would be a thorough investigation.(b)(4) also expressed that ability takes safety very seriously.Email received to (b)(4) 2014: (b)(6) communicated that he successfully installed, onto (b)(6), a rush87 replacement foot ability had sent.Prosthetist and patient were pleased.Call (b)(4) 2014: (b)(4).Confirmed everything went well and both prosthetist and patient are satisfied.

• Brand Name: RUSH81
• Type of Device: PROSTHETIC FOOT
• Manufacturer (Section D): ABILITY DYNAMICS LLC; tempe AZ
• Manufacturer Contact: 2082 e university dr; tempe, AZ 85281-0000 ; 4803611714
• MDR Report Key: 3916350
• MDR Text Key: 4666139
• Report Number: 3008584163-2014-00001
• Device Sequence Number: 1
• Product Code: ISH
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2017
• Device Model Number: 81
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2014
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 67