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

Catalog Number 320-20-00

Device Problems Device Slipped (1584); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); No Code Available (3191)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2014.Revision of shoulder components due to loosening.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, activity level, and/or trauma would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.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 most likely cause of the revision for the loosening of the shoulder joint device is related to trauma from the patient fall.This device is used for treatment, not diagnosis.Corrected data: device evaluated by mfr: no evaluation pending.

Event Description

It was reported from the united kingdom that a patient experienced a revision surgery after a fall.The patient presented to the healthcare provider with poor mobility (stiffness) and had an x-ray that showed device loosening.The patient reported that he had fallen.Revision of the shoulder components is due to loosening of the baseplate, all implants were removed, and a spacer as put in situ."revision surgery to follow".No additional information has been provided, follow up attempts for information have been made.There is no indication that the devices malfunctioned.No additional information is provided.This is one of eleven products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00809, 1038671-2017-00810, 1038671-2017-00811, 1038671-2017-00812, 1038671-2017-00813, 1038671-2017-00814, 1038671-2017-00815, 1038671-2017-00816, 1038671-2017-00817, and 1038671-2017-00819.

• Brand Name: REVERSE TORQUE DEFINING SCREW KIT
• Type of Device: REVERSE TORQUE DEFINING SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7021043
• MDR Text Key: 91802358
• Report Number: 1038671-2017-00818
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/27/2019
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR