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

Catalog Number MCP-100-30D-WW

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Swelling (2091); Therapeutic Response, Decreased (2271); Test Result (2695)

Event Date 11/17/2015

Event Type  malfunction  

Event Description

It was reported the device fractured.It was reported that the patient is a mechanic, he works with his hands.He had returned to work and was on light duty.The patient reported hitting/jamming his finger."the detailed description by the patient did not sound like anything that would have caused the implant to fracture." following the incident, the patient had pain and swelling, leading to the office visit and x-rays where the fracture was discovered.Currently the patient is removed from working and is waiting for further treatment recommendation from the care team.A revision procedure is expected.Operative report from initial surgery (b)(6) 2015: preoperative diagnosis: severe osteoarthritis of the left mcp joint.Procedure: left hand third mcp joint: resectional arthroplasty with ascension orthopedics pyrocarbon implant (size #30).Application of volar splint.Summary of report: uneventful implantation procedure.

Manufacturer Narrative

Additional information received 18nov2015: the revision surgery has been completed as of yesterday (b)(6) 2015.I have the explanted implants on hand that have been washed and sterilized.Integra has completed their internal investigation on 1dec2015.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: the review of manufacturing records showed no evidence of nonconformance that could have caused or contributed to the reported defect.(b)(4).Conclusion: the investigation determined that the fracture is most likely the result of a traumatic injury suffered by the patient.

Event Description

• Brand Name: MCP SZ. 30 DISTAL 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: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5105584
• MDR Text Key: 26965866
• Report Number: 1651501-2015-00035
• 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,distri
• Reporter Occupation: Dental Assistant
• Type of Report: Followup
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCP-100-30D-WW
• Device Lot Number: 142698T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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
• Patient Outcome(s): Required Intervention