MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MEMOFIX STAPLE 15MM X 12MM X 12MM; MEMOFIX STAPLE SYSTEM

Catalog Number MS151212

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported one of the memofix staple was broken and led to revision surgery.The primary procedure was on (b)(6) 2021 with left radioscapholunte fusion (partial wrist fusion).After two to four weeks postop, one of four implanted staples was broken (2 staples in radiolunate and 2 staples in radioscaphoid).The broken staple caused unstable and translated or misaligned the radiolunate construct, which was indicative of non-union.The surgeon had to perform second surgery on patient¿s left wrist to revise fusion construct on (b)(6) 2021.Two 15x12x12 staples were removed from the radiolunate and revised with synthes headless compression screws.

Manufacturer Narrative

The memofix staple was returned for evaluation.Failure analysis: parts were returned for evaluation.The return included two (2) staples total.One of the staples was broken such that a leg of the staple was completely broken off from the body of the staple.The failure was confirmed.Visual examination of the intact staple identified no damage or deformity.Root cause: a definitive root cause for the difficulties with the memofix staples could not be determined.

Event Description

N/a.

• Brand Name: MEMOFIX STAPLE 15MM X 12MM X 12MM
• Type of Device: MEMOFIX STAPLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 12351253
• MDR Text Key: 267640051
• Report Number: 1651501-2021-00034
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K123926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MS151212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1