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

Catalog Number 320-20-00

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 06/16/2017

Event Type  Injury  

Manufacturer Narrative

Pending device return and evaluation.

Event Description

Index surgery: (b)(6) 2013.Revision of reverse total shoulder due to disassociation of the humeral adapter tray from the primary humeral stem.The torque defining screw backed out of the stem, causing the tray, with liner intact, to disassociate from the stem and float in the joint space.

Manufacturer Narrative

The compliant products were received for analysis.The condition of the humeral liner disassociation was confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical) wear on the inferior edge of the liner appears consistent with articulating with the patient's glenoid bone or glenosphere following the reported adapter tray disassociation.Threads of torque defining screw, the deformed threads of the screw appear consistent with not being fully seated in the humeral adapter tray.The wear on the top portion of the threads appears consistent with articulating with the adapter tray as it became disassociated from the humeral stem.Wear on mating feature of adapter tray appears consistent with articulating with the torque defining screw and humeral stem.The frequency of occurrence ranking scale is very low; therefore, this does not appear to be a design issue.The company is not aware of any other complaints involving parts from any of these manufacturing lots (adapter tray, screw kit, and humeral liner).According to sales data, (b)(4).A review of the device history record showed that the humeral stem and torque defining screw were accepted with conformance to the device requirements.Therefore, this does not appear to be manufacturing-related.The revision reported was likely the result of inadequate seating of the torque screw at the time of initial surgery, which allowed for disassociation of the tray from the stem.It is noted in the labeling that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Device specific risk include: fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.Only qualified surgeons knowledgeable in anatomy, biomechanics, and reconstructive surgery should use these devices.The surgeon must be fully knowledgeable about all aspects of the surgical technique and use these implants in accordance with the respective indications and contraindications.It is essential that the proper surgical technique be used.There is no patient information provided to assess the patient risk/clinical factors, there are no x-rays or surgical notes.This device is used for treatment not diagnosis.

Event Description

No additional information has been provided on the patient or the event.This is one of threeproducts involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00410 and 1038671-2017-00412.

• Brand Name: REVERSE TORGUE DEFINING SCREW KIT
• Type of Device: SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6664713
• MDR Text Key: 78306984
• Report Number: 1038671-2017-00411
• 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: 04/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/04/2018
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR