MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS FUTURA IMPLANT; FOREFOOT IMPLANTS

Catalog Number XXX-FUTURA IMPLANT

Device Problems Device Reprocessing Problem (1091); Problem with Sterilization (1596); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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

Three of 3 reports: other mfg report numbers: 1651501-2017-00021 / 1651501-2017-00022.It was reported that implants were sent to facility for use without proper sterilization.The sterilization label was yellow instead of green.No further information available.

Manufacturer Narrative

Integra has completed their internal investigation on september 5, 2017.Results: no products were returned to integra for investigation.As such, a failure analysis could not be conducted.Dhr review; a review of the lot record could not be conducted as no part number or lot number was provided with the complaint.Complaints history; a review of the complaint records for the same product description (futura) for the alleged hazardous situation/failure mode (sent without proper sterilization) showed two other complaint having been received, when all available records were searched.The complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode, over the number of surgeries or units sold during the period of the review.Complaint rate: total # complaints = 3.Number of procedure = 2266 procedures as of (b)(6) 2017.Complaint rate = 3/2266*100 = 0.13%.Conclusion: as the implant in question was not returned for investigation, a definitive root cause could not be found.However, possible root causes can be postulated based on the information supplied by the source of the complaint, and information gathered by integra subsequently.The first allegation, that the product was ¿reprocessed,¿ appears to stem from a misreading of the symbol key label applied to the box.This allegation was also made for two similar complaints that originated a week before this one.In those complaints, the tornier/wright representative contacted stated, ¿in the picture of the single box, the symbol key is shown.The symbol key pictured ¿baw-0843¿ has an example date shown of ¿2011 06¿.This does not represent an original expiration date, only a dummy date code.¿ the true expiration date is shown on the end and top of each box.In viewing both the generic symbol key label and the label with the specific lot information, the hospital apparently thought the 2011 date was the original sterilization date, and that the later dates on the label on the end of the box represented a second sterilization.The second allegation was that, ¿all eto labels for each implant did not indicate proper eto exposure verifying sterilization.(note: labels to turn to green with proper sterilization, some labels were green and some were yellow).¿ it also stated, ¿these items were sent to facility by integra for use without proper sterilization.¿ the ¿eto labels,¿ or eto sterilization process indicators (as the manufacturer etigam calls them), are, by turning green, designed only to indicate exposure to eto gas, and thus do not verify package sterility.Sterility is established through process validation and by the biological indicators placed in each sterilization run.The attached ¿yellow and green dot photo¿ shows the product in question from the similar complaints.Two different lots in the photo show, on one package, a green eto indicator, while a yellow one is present on another package within the same lot.Packages with yellow eto indicators were subsequently opened by both the hospital staff and an integra sales representative, and the indicators affixed to the pouches were green, affirming exposure to eto gas.If the eto gas wasn't reaching the outer box, then the indicators on the pouches inside would likely also be yellow instead of green.A capa performed by the packaging supplier, qts, found that the units in question were from the same sterile lot.No anomalies were found.The sterilization supplier also reviewed their records and found nothing unusual.Inquiries made with the manufacturer of the eto indicators, etigam, did not reveal any problems with the indicator lot in question (qts p/n qts055-03, lot# 000-3-150720).However, their general information document notes the importance of storage conditions for the eto indicators: recommended storage conditions: (before and after exposure): the sterilization process indicators must be stored in dark and dry conditions, between 10 and 30 c (50 and 86 f).Also: sterilization process indicators may not perform properly unless stored under proper conditions as stated on the package label.Sterilization process indicators must be protected from exposure to excessive daylight and heat, chemicals, chemical vapours and liquids.The colour of processed indicators may fade out under influence of excessive daylight.Based on the above, the most likely root cause is that some of the eto indicators or packages were exposed to environmental conditions that caused the eto indicators to change to a yellow color, most likely due to sunlight.

• Brand Name: FUTURA IMPLANT
• Type of Device: FOREFOOT IMPLANTS
• 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: 6623667
• MDR Text Key: 77298500
• Report Number: 1651501-2017-00023
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• PMA/PMN Number: K981194
• 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
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-FUTURA IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 09/05/2017
• Supplement Dates FDA Received: 09/13/2017
• 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