MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SILICONE MCP SZ 10

Catalog Number SMCP-500-10-WW

Device Problems Break (1069); Cut In Material (2454); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); No Code Available (3191)

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

This is 2 of 4 reports.Other mfg report numbers: 1651501-2017-00033, 1651501-2017-00035, 1651501-2017-00036.It was reported that the initial silicone mcp arthroplasty was performed on (b)(6) 2016.Revision case was scheduled for (b)(6) 2017; once the surgeon noticed that the index finger of the implants had failed, he decided to check all of the other implants (middle finger, ring finger, & small finger) had also failed or almost failed.The index finger silicone implant had broken at the hinge/distal stem of the size 20 implant.This happened as well to the middle finger size 20 implant.The size 10 ring finger implant had not completely failed but it had a visible cut at the hinge/distal stem section.The size 10 small finger implant failed in the same fashion.

Manufacturer Narrative

Additional information received on september 12, 2017: (investigation remains unchanged) the reason for the initial implantation on (b)(6) 2016 is unknown.Reason for revision surgery: the patient was experiencing some pain and discomfort in the 6 months to 1 year time frame from the initial implantation.The patient does not have any degenerative diseases nor were they using their hand in an excessive way.The surgeon is still unsure as to why the implants failed initially.

Manufacturer Narrative

Integra has completed their internal investigation on september 1st, 2017.Results: evaluation of returned device; visual examination confirms the devices were broken / fractured in various degrees, most probably due to excessive load placed on the prostheses.Dhr review; no nonconformances that may have caused/contributed to the reported complaint.Complaints history; a search of the results of the product id field containing smcp-500-20-ww or smcp-500-10-ww was conducted and showed 1 complaint of post-operative smcp breakage outside of the four captured in this report.Within the past two years ((b)(6) 2015 - (b)(6) 2017), there have been 650 smcp surgeries performed.This represents (b)(4) overall failure rate, which does not represent an adverse trend.In review of these complaints, the highest severity of the complaints reviewed is provisionally acceptable as surgical intervention was required: this does represent an adverse trend.Conclusion: the complaint record does not provide details related to the reason for the revision surgery, the condition of the patient or the type of activities she performed after the primary surgery; therefore, the root cause of this event could not be established.If additional relevant information is received at a later date, this investigation will be reopened to address any new finding.Excessive activity of the affected joint; uncorrected or recurrent deformity of the joint; incorrect sizing of the implant; inadequate soft tissue on bony support; or implant malposition have been identified as possible causes for the silicone flexible hinge prosthesis breakage or dissociation.

• Brand Name: SILICONE MCP SZ 10
• Type of Device: SILICONE 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: 6810376
• MDR Text Key: 83238497
• Report Number: 1651501-2017-00034
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• PMA/PMN Number: K022892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Device Operator: Health Professional
• Device Catalogue Number: SMCP-500-10-WW
• Device Lot Number: 152843T
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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