MAUDE Adverse Event Report: ARTHREX, INC. SABRE, SJ 2.0MM X 7CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number SABRE, SJ 2.0MM X 7CM

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported (via fda medwatch letter mw5095971) that the following incident had been reported by the facility: a laparoscopic procedure was performed without any noticeable issues.A disposable arthrex sabre type shaver was used.This shaver is 7cm long with a 2mm tip enclosed in a sheath.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 5 cm long, had broken during use and was still inside the patient's ankle tissue.Thee was no perceptible feeling or indication of device failure.When removed from the patient, it was pulled out 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.Device reported was ar-7200sr, lot number not provided.

• Brand Name: SABRE, SJ 2.0MM X 7CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 10563004
• MDR Text Key: 207922776
• Report Number: 1220246-2020-02189
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867041271
• UDI-Public: 00888867041271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SABRE, SJ 2.0MM X 7CM
• Device Catalogue Number: AR-7200SR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other