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

Catalog Number 320-11-00

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/22/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Index surgery: (b)(6) 2016.Revision of right shoulder components due to baseplate loosening, scapular spine fracture and possible glenoid vault fracture.The case report form indicates this is definitely not related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Engineering evaluation noted that the revision reported was likely the result of the reported bone fracture(s), which allowed for the baseplate to loosen.

Event Description

Index surgery: (b)(6) 2016.Revision of right shoulder components due to baseplate loosening, scapular spine fracture and possible glenoid vault fracture.The case report form indicates this is definitely not related to devices and definitely related to procedure.This event report was received through clinical data collection activities.

• Brand Name: REVERSE TORQUE DEFINING SCREW ASSEMBLY
• Type of Device: SCREW ASSEMBLY
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 6986574
• MDR Text Key: 90529485
• Report Number: 1038671-2017-00787
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 72