MAUDE Adverse Event Report: ARTHREX, INC ARTHREX DISPOSABLE SHAVER DEVICE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number AR-7200SR

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/06/2020

Event Type  Injury  

Event Description

A laparoscopic procedure was performed without any noticeable issues.A disposable arthrex sabre type shaver was used.This shaver is 7 cm long with a 2mm tip enclosed in a sheath.(fig 1; fig 2) both the attending surgeon and the surgical resident had used the arthrex sabre type shaver before without any issues.When the resident was done using the shaver, he extracted it as one unit.Unbeknownst to the surgical team, a piece of the shaver, approximately 5cm long, had broken during use and was still inside the patient's ankle tissue.There was no perceptible feeling or indication of device failure.When removed from the patient, it was pulled out and within the sheath and appeared to be normal.While in the pacu, a post-op x-ray was taken, as this was the regular practice of the surgeon in order to review the ankle post-procedure.The post-op x-ray in the pacu revealed an artifact which was determined to be the tip of the shaver.The broken fragment was removed in sterile aspect manner in the pacu without incident.X-rays were repeated to ensure the entire tip piece was removed.The arthrex rep was present that day and said he had heard of other instances of the shaver tip breaking but he did not provide details.Fda safety report id # (b)(4).

• Brand Name: ARTHREX DISPOSABLE SHAVER DEVICE
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC; naples FL 34108
• MDR Report Key: 10384612
• MDR Text Key: 202423780
• Report Number: MW5095971
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR-7200SR
• Device Catalogue Number: AR-7200SR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR