MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX; STAPLE, FIXATION, BONE

Model Number	AR-8717DS-0910
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During administration of the staple to the affected toe the drill bit became lodged in the skin protector sheath.Drill bit became permanently stuck.

• Brand Name: ARTHREX
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 10747063
• Report Number: 10747063
• Device Sequence Number: 11182314
• Product Code: JDR
• UDI-Device Identifier: 00888867288058
• UDI-Public: (01)00888867288058
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/07/2020
• Report Date (Section F): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR-8717DS-0910
• Device Catalogue Number: AR-8717DS-0910
• Device Lot Number: 0071102087
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 87
• Date Report Sent to FDA: 10/07/2020