MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MCP SZ. 05 PROXIMAL WW

Catalog Number MCP-110-05P-WW

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that the proximal mcp implant was implanted upside down.The surgeon is an experienced user but seemed to have difficulty during this case.During the implantation, the implant was positioned and removed several times.X-rays provided show the implant mal-positioned.A revision surgery has been discussed and scheduled with the patient.Currently the device remains implanted and the patient is in a postoperative splint.

Manufacturer Narrative

Integra has completed their internal investigation on january 23, 2017.The investigation included: methods: review of device history records, review of complaints history.Results: attempts for additional information and product return have been unsuccessful to date; therefore, no failure analysis has been performed.Dhr review; review of manufacturing records showed no evidence of a nonconformance that may have caused or contributed to the reported event.Complaints history; a search of the results of the field containing ¿mcp¿ january 2012 to present showed no previous complaints of an mcp implant being implanted upside down.During this period of time, there have been (b)(4) mcp surgeries performed.This represents a (b)(4) overall failure rate.Conclusion: as the device has not been returned and attempts for additional information have been unsuccessful to date, the root cause of the report cannot not be confirmed at this time; however, based on the information provided, the event appears to be due to surgeon difficulties encountered during the implant process.Should additional information be provided, the investigation will be updated accordingly.

• Brand Name: MCP SZ. 05 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6227006
• MDR Text Key: 64020085
• Report Number: 1651501-2016-00050
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCP-110-05P-WW
• Device Lot Number: 154068T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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