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

Catalog Number 320-20-00

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Joint Dislocation (2374); No Code Available (3191)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2018.Revision due to dislocation after patient fall.

Manufacturer Narrative

Mdr has been voided due to the surgeon feeling like the patient was non-compliant on many levels.

Event Description

Index surgery: (b)(6) 2018.Revision due to dislocation after patient fall.

Manufacturer Narrative

In a review of the labeling it is a known complication that a patient's age, weight, activity level 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.Patient non-compliance with post-op procedures and wound care can negatively affect patient healing and possibly cause wound site infection.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 cause of revision surgery of the shoulder joint devices for dislocation is most likely due to the patient's traumatic event of falling in the shower.This device is used for treatment, not diagnosis.

Event Description

It was reported that the patient had a revision for the reverse total shoulder due to a fall in the shower, the traumatic event caused a dislocation.The patient is reported to be non-compliant for "a large variety of reasons", the patient had picked at the incision and caused it to open.While the surgeon was replacing the shoulder devices, they "looked for infection" and cleaned out the wound.The patient was reported to be treated for an infection of the surgical site that was caused by the patient "digging and picking" at the incision.The surgeon stated to the representative that the patient is responsible for the surgical site infection.There is no indication or complaint of device malfunction.No additional information is provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00250, 1038671-2018-00251, 1038671-2018-00252, 1038671-2018-00254.

• 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: 7365613
• MDR Text Key: 103305035
• Report Number: 1038671-2018-00253
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/26/2022
• Device Catalogue Number: 320-20-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR