MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; LARGE REAMER

Catalog Number 315-35-14

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2017

Event Type  malfunction  

Event Description

It was reported that during an orthopedic shoulder surgery the surgeon attempted to use the cannulated system to set k-wire.The wire bound in the guide because they could not get straight on access (k-wire and guide part numbers unknown).The surgeon broke the large reamer during use because of levering against the humerus (315-35-14) and broke the x-large reamer (315-35-15).The sales representative was present at the surgery and reported no device fragments fell into the surgical site.The surgery continued and was completed without additional issues.There was a minor delay of surgery and there was no reported patient injury, adverse event, or clinical consequence to the patient.No additional information was provided by the reporter related to this event.

Manufacturer Narrative

As a result of an fda inspection conducted in jan 2020, exactech, fei 1038671, has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.The devices in question were not returned to exactech for analysis.The broken instruments reported were likely the result of inadequate exposure of the joint, preventing "straight on" access for the k-wire, guide, and reamers.Exactech ifu 700-096-004 states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: (1) appropriate reading of the literature, and (2) training in the operative skills and techniques required for total knee arthroplasty surgery, and (3) reviewing information regarding use of instrumentation.It is a clinical standard of practice in the operating room that all instruments should be visually and functionally inspected before use, these guidelines are from standard association of peri-operative registered nurses (aorn) guidelines.Surgeons are to be familiar and knowledgeable with all exactech instrumentation, devices and proficient with surgical techniques.The devices reported in this event are used for treatment not diagnosis.Based on a review of all available information, there is no evidence to reasonably suggest the reported instruments malfunction is related to any manufacturing issues or design issues, nor did it lead to any reported patient impact.An investigation was conducted and concluded that the likely cause of the issues was the result of inadequate exposure of the joint, preventing "straight on" access for the k-wire, guide, and reamers.

• Brand Name: EXACTECH
• Type of Device: LARGE REAMER
• 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: kate jacobson ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 13938047
• MDR Text Key: 290182965
• Report Number: 1038671-2022-10005
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 315-35-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other