MAUDE Adverse Event Report: ARTHREX, INC.; ARTHREX DISSECTOR SJ

Catalog Number AR-7300DS

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

When beginning ankle arthroscopy procedure, dr (b)(6) started using the shaver inside the joint, and the end of the shaver broke off.Fluoroscopy used to locate broken segment.Attempt to remove segment arthroscopically was unsuccessful.Arthrotomy performed to remove segment.Scheduled scope procedure was 45min.Additional or/anesthesia time was a result of retrieval of segment.Complete removal of segment confirmed by pa & lat x ray.Shaver and segment sent to risk.

• Type of Device: ARTHREX DISSECTOR SJ
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 6833872
• MDR Text Key: 84109841
• Report Number: 6833872
• Device Sequence Number: 0
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 10091577
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 39 YR