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

Catalog Number 320-20-00

Device Problems Material Separation (1562); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 03/27/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to humeral liner disassociation.

Event Description

It was reported that a patient experienced a shoulder device revision for poly disengagement due to bony impingement.The initial implant date is unknown.The patient was stable leaving the or.No additional information has been provided about the patient or event.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00311, 1038671-2018-0312 and 1038671-2018-0313.

Manufacturer Narrative

The complaint products were not returned for analysis.The condition of revision due to liner disassociation was not confirmed.The design of the shoulder system has been in the field since 2007.The company is aware of 5 other complaint reports involving revised shoulder components due to humeral liner disassociation since 2014.Sales data for humeral liners 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.There has been no patient information provided; therefore, the patient risk/clinical factors cannot be assessed.It is noted in labeling and ifu review- that contraindications include: patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.Device specific risks - 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.Excessive wear of the implant components secondary to impingement of components or damage of articular surfaces.Possible detachment of the coating(s) on the components, potentially leading to increased debris particles.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.This device is used for treatment not diagnosis.Information about the event and patient have been requested.No information has been provided.Serial number (all serial number's were reported incorrectly as they are the implanted devices serial #'s not the explanted.The explanted device serial numbers are unknown).

• Brand Name: REVERSE TORQUE DEFINING SCREW KIT
• Type of Device: SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7432166
• MDR Text Key: 105514209
• Report Number: 1038671-2018-00313
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention