MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MEMOFIX STAPLE 12MM X 10MM X 10MM; MEMOFIX STAPLE SYSTEM

Catalog Number MS121010

Device Problem Insufficient Information (3190)

Patient Problems Synovitis (2094); Implant Pain (4561)

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 facility reported a patient had a left wrist scaphoid excision 4-corner fusion.Approximately 6 months following the primary procedure the patient developed hardware pain and synovitis.Hardware was removed and the patient was clinically fused.

Event Description

N/a.

Manufacturer Narrative

The memofix staple (ms121010) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

The memofix staple was returned for evaluation.Failure analysis: parts were returned for evaluation.Visual examination of the staples identified no damage or deformity.As no physical indications of failure were identified on the returned parts and x-rays were not provided to show the staples in-situ, the failure could not be confirmed.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 12MM X 10MM X 10MM
• Type of Device: MEMOFIX STAPLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 12323743
• MDR Text Key: 266585320
• Report Number: 1651501-2021-00033
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MS121010
• 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