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

Catalog Number 320-11-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Sensation in Eye (1869); Perforation (2001); Weakness (2145); Joint Disorder (2373)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

Event Description

Index surgery: (b)(6) 2016.Revision of left shoulder components due to subscapularis tear.Patient reported a "rolling sensation" and is very weak.This event report was received through clinical data collection activities.

Event Description

There is no further information.The devices will not be returned.Associated mfrs: 1038671-2017-00217, 1038671-2017-00218, 1038671-2017-00219, & 1038671-2017-00220.

Manufacturer Narrative

Ifu information states, 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 activity and trauma affecting joint replacements have been associated with premature failure, also a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.The patient is over (b)(6).There is no indication that there is a device related problem/malfunction, there is no allegation against any device.The most likely cause of the reported event is related to the underlying conditions of the patient.This device is used for treatment not diagnosis.

• Brand Name: REVERSE TORQUE DEFINING SCREW ASSEMBLY
• Type of Device: SCREW ASSEMBLY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6484929
• MDR Text Key: 72508963
• Report Number: 1038671-2017-00218
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 320-11-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 82