MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MCP SZ. 50 PROXIMAL WW

Catalog Number MCP-100-50P-WW

Device Problem Fracture (1260)

Patient Problems Pain (1994); Injury (2348)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to date; however, images provided show that the device was removed in three pieces.If the device is returned to integra, the complaint will be updated accordingly.Review of the dhr for lot 152948t shows that no nonconformances were generated and all units in the lot met specifications at the time of final release.Based on the visual review of the explanted components (images), it is unclear how/when the fracture occurred; however, the fracture appearance is consistent with a rapid brittle, bending fracture.It is unclear if the breakage occurred during implant (during impaction) and went unnoticed or occurred post-implant due to patient action.

Event Description

A distributor reported that on (b)(6) 2019, a patient underwent revision of a proximal pyrocarbon mcp implant (id mcp-100-50p-ww - mcp sz.50 proximal ww) that was used as a hemi replacement in the right index finger.Revision surgery was indicated 6-8 months post initial surgery due to a fractured stem.The patient presented due to complaining of pain.No known incident was reported that to have caused the fracture, and the patient was reported to have followed the postoperative instructions.

• Brand Name: MCP SZ. 50 PROXIMAL WW
• Type of Device: MCP
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362319
• MDR Report Key: 9162567
• MDR Text Key: 168608061
• Report Number: 1651501-2019-00041
• Device Sequence Number: 1
• Product Code: NEG
• Combination Product (y/n): N
• PMA/PMN Number: P000057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCP-100-50P-WW
• Device Lot Number: 152948T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• 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