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

Catalog Number 300-20-02

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problems Injury (2348); Joint Disorder (2373)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

During surgery the patient's proximal humerus was damaged.Bone graft was applied to repair the structure.

Event Description

It was reported that there was an issue with a torque defining screw.The humeral implant needed to be removed after implantation to determine why the torque screw couldn't be "broken off." the amount of torque to break off this screw was reported by surgeon to be way higher than published torque.Due to the amount of torque needed to break the screw, the humeral implant crushed the cancellous bone in the proximal humerus and bone grafting was required to get a secure fit.The case was finished after replanting the humerus 3 times using addition autograft due to humeral component torqueing because of the amount of force needed to break the screw.An additional screw used with the same result.No additional information is available.

Manufacturer Narrative

The complaint product was not received for analysis.Following the completion of a company test, a mechanical test will be performed on a sibling device to verify the amount of torque required to break the screw.If the results of the test are outside the tolerance range, this evaluation will be amended.The manufacturing lot information for the torque defining screw piece was reviewed.Measures have been initiated to ensure that torque defining screws are designed and manufactured after sufficient design control activities are completed and documented.The reverse torque defining screw malfunction reported was possibly the result of not simultaneously using a counter torque as a torque was applied to the superior portion of the screw.In a review of labeling - as part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Only qualified surgeons are to use these products: who are fully knowledgeable about all aspects of the surgical technique and use of these implants, have full knowledge about the system compatibility's, and must be fully trained to properly use the system and instrumentation.There is also the potential for surgical intervention/revision and unintended bone fractures.Properly following the operative technique and using all the appropriate instruments, will result in proper implementation of the device.According to the operative technique, with one hand, the t-handle will tighten the screw until the superior portion disengages, which will occur at an applied torque of 11 n·m.To prevent the stem from rotating within the canal, a counter torque must be simultaneously applied using the replicator plate handle.This device is used for treatment not diagnosis.

• Brand Name: EQUINOXE TORQUE DEFINING SCREW KIT
• Type of Device: SCREW KIT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• MDR Report Key: 6680291
• MDR Text Key: 79037346
• Report Number: 1038671-2017-00425
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K042021
• 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: 06/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 300-20-02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 06/28/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other