MAUDE Adverse Event Report: GENESYS SPINE BINARY ANTERIOR CERVICAL PLATE; SCREW DRIVER

Model Number GCP240

Device Problems Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

The surgical staff and end users of this device should have caught this anomaly since the ifu requires an inspection of all parts for corrosion.The materials and passivation requirements for the gcp240 are in-line with all reusable stainless steel instruments and should not result in any corrosion under normal usage.Grade 440 stainless steels exhibit excellent resistance to mild acids, alkalis, foods, fresh water and air.This grade of steel is commonly used for steam sterilized medical devices as it is corrosion resistant.Passivation per astm a967 is also required per the drawing; this process cleans stainless steel parts and provides additional corrosion resistance.A review of the manufacturing record shows the parts were made in compliance of these specifications.All required material certifications and passivation records document the instruments were properly manufactured and handled.There have been no other reported instances of corrosion for this lot of devices over the prior 12 months.

Event Description

After a successful acdf procedure patient was reported to have a post-operative infection.It was noted that 2 of the instruments being used in the procedure appeared to have rust spots on them.

• Brand Name: BINARY ANTERIOR CERVICAL PLATE
• Type of Device: SCREW DRIVER
• Manufacturer (Section D): GENESYS SPINE; austin TX
• Manufacturer Contact: dave lamb ; 1250 s capital of tx highway; building three, suite 600; austin, TX 78746 ; 5123817094
• MDR Report Key: 5060309
• MDR Text Key: 25181543
• Report Number: 3008455034-2015-00005
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Not Applicable
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GCP240
• Device Lot Number: 11794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ANTERIOR CERVICAL PLATE AND CERVICAL SCREWS.
• Patient Outcome(s): Other