MAUDE Adverse Event Report: ARTHREX, INC. KNEE SCORPION; MANUAL INSTR, GENERAL SURGICAL

Model Number KNEE SCORPION

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales representative via sems that an ar-12990 knee scorpion had an issue, the top jaw completely snapped off.The jaw was retrieved, and the case was completed using another knee scorpion hand instrument.No adverse event or patient harm.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.On (b)(6) 2023, the sales representative provided the following information via email: this occurred during a subscap repair using the compression bridge cerclage cables during a total shoulder procedure.There was no case delay reported.

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.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: KNEE SCORPION
• Type of Device: MANUAL INSTR, GENERAL 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: emily shafer ; 8009337001
• MDR Report Key: 17689676
• MDR Text Key: 322714813
• Report Number: 1220246-2023-07790
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867196322
• UDI-Public: 00888867196322
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/06/2023

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
• Device Operator: Health Professional
• Device Model Number: KNEE SCORPION
• Device Catalogue Number: AR-12990
• Device Lot Number: 10382445
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 09/06/2023
• Date Device Manufactured: 09/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1