MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS PLATE, CARPAL LARGE; UNI2 TOTAL WRIST IMPLANT SYSTEM

Catalog Number 261401

Device Problem Material Separation (1562)

Patient Problem Failure of Implant (1924)

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

An orthopedic surgeon reported that the polymer component of total wrist implant system disassociated from the carpal plate six (6) months post operation.A revision surgery was required.

Manufacturer Narrative

The part has not been returned for evaluation, but x-ray images were provided.Failure analysis - examination of the x-rays showed that the implanted uni2 system was dissociated.The failure was confirmed.According to the instructions for use (ifu) for the uni2 system; contraindications for the use of the uni2 system include ¿poor bone quality which may affect the stability of implants¿.Additionally, warnings include that ¿excessive physical activity and trauma [may result in] premature failure by loosening, fracture, or wear of the implants¿.If the part is later returned, this investigation may be reopened and updated.

Event Description

N/a.

Manufacturer Narrative

Dhr - lot px0075 - a review of the manufacturing records found no issues or problems which could have caused or contributed to the alleged failure.

• Brand Name: PLATE, CARPAL LARGE
• Type of Device: UNI2 TOTAL WRIST IMPLANT SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12523974
• MDR Text Key: 273088761
• Report Number: 1651501-2021-00043
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• PMA/PMN Number: K030037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2019
• Device Catalogue Number: 261401
• Device Lot Number: PX0075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 10/08/2021; 12/16/2021
• Supplement Dates FDA Received: 10/27/2021; 01/15/2022
• Date Device Manufactured: 05/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1