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
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10563004
• Report Number: 1220246-2020-02189
• Device Sequence Number: 2977566
• Product Code: GFA
• UDI-Device Identifier: 00888867041271
• UDI-Public: 00888867041271
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: SABRE, SJ 2.0MM X 7CM
• Device Catalogue Number: AR-7200SR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other