MAUDE Adverse Event Report: EXACTECH, INC REVERSE TORQUE DEFINING SCREW KIT

Catalog Number 320-20-00

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Failure of Implant (1924); Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the device was not returned for evaluation.

Event Description

Index surgery: (b)(6) 2015.Revision - reason not reported.

Event Description

It was reported that a patient experienced a fall that initiated a right shoulder surgical intervention for a disassociated glenosphere that occurred on an unknown date.During the surgical intervention it was discovered that there had been no set screw initially implanted.The surgeon reset the glenosphere and implanted a set screw.The patient is reported to be doing well and attending follow-up appointments with the surgeon.The revision was due to a post traumatic event of a fall, there is no allegation of malfunction against a device.There is no additional information on this event or patient.This is one of eleven products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00143, 1038671-2017-00144, 1038671-2017-00145, 1038671-2017-00146, 1038671-2017-00147, 1038671-2017-00148, 1038671-2017-00150, 1038671-2017-00151, 1038671-2017-00152 and 1038671-2017-00153.

Manufacturer Narrative

In a review of the labeling it is noted that a patient's age, weight, or activity level/excessive activity and trauma would cause the surgeon to expect early failure of the system.All patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.According to the operative technique guide "the glenosphere can then be maneuvered onto the glenoid plate by using the glenosphere locking screw as a guide to the central hole and to ensure it is properly aligned relative to the bone cage.When the glenosphere is fully seated, drive the screw until it locks the assembly together." the design of the shoulder system has been in the field since 2007.The company is aware of 11 other complaint reports of glenosphere cases reported as "post traumatic event" since 2014.Sales data for the glenosphere was used to calculate an approximate complaint occurrence rate of less than 0.5%.This is considered "very low" according to the frequency of occurrence ranking scale.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical intervention to reset the glenosphere and implant a set screw are due to the fall that the patient had causing disassociation of the glenosphere.This device is used for treatment not diagnosis.Additional information about the patient and event have been requested.No new information has been provided.

• Brand Name: REVERSE TORQUE DEFINING SCREW KIT
• Type of Device: KIT
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6387972
• MDR Text Key: 69380739
• Report Number: 1038671-2017-00149
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/14/2020
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention