MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS NEXA FGT IMPLANT SIZE 50; TOE JOINT REPLACEMENT

Catalog Number FGT-50

Device Problems Device Expiration Issue (1216); Delivered as Unsterile Product (1421); Device Disinfection Or Sterilization Issue (2909)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

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

One (1) of 3 reports - other mfg report numbers: 1651501-2017-00022 / 1651501-2017-00023.It was reported that the device was implanted and the sterilization sticker was yellow instead of green.They did some further investigating and removed the top label to find another label underneath that stated the product expired in 2011.No further information available.

Manufacturer Narrative

Integra has completed their internal investigation on september 12, 2017.Results: dhr review; review of the lot record could not be conducted as the sterilization lot records could not be retrieved.Complaints history; a review of the complaint records for the same product description (futura or fgt) for the alleged hazardous situation/failure mode (product not sterile) showed two other complaint having been received, when all available records were searched (q4 2015 to present).The complaint rate was calculated based on the number of devices affected by the hazardous situation or failure mode (3), 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.One allegation stated that the product expired in 2011.This appears to stem from a misreading of the symbol key label applied to the box.In investigating this claim, integra contacted the company who had labeled the product.The 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 the generic symbol key label, the hospital staff apparently thought the 2011 date was the original sterilization date.The other allegation referred to the yellow ¿sticker,¿ which should have been green, leading them to think the product was not sterile.The ¿stickers,¿ or eto sterilization process indicators (as the manufacturer 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.

• Brand Name: NEXA FGT IMPLANT SIZE 50
• Type of Device: TOE JOINT REPLACEMENT
• 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: 6623660
• MDR Text Key: 77423495
• Report Number: 1651501-2017-00021
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FGT-50
• Device Lot Number: CT0416057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2017
• 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