MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MCP SZ. 30 PROXIMAL WW

Catalog Number MCP-100-30P-WW

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.As such, a failure analysis could not be conducted.A review of the lot records was conducted, and did not find any indication of problems that could have caused or contributed to the complaint.As the implant was not returned for investigation, a possible root cause could not be found.

Event Description

A customer reported that on (b)(6) 2019, a pyrocarbon mcp (id (b)(6)) had snapped during a metacarpophalangeal joint (mcpj) arthroplasty.The snapped implant was noticed on x-rays two (2) days post-surgery and has been left implanted as it did not appear to be affecting the patient.The patient had no issues and so no plans to revise at this stage.

• Brand Name: MCP SZ. 30 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 ; 6099362393
• MDR Report Key: 8493334
• MDR Text Key: 141329449
• Report Number: 1651501-2019-00010
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCP-100-30P-WW
• Device Lot Number: 17349ST
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2019
• 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