MAUDE Adverse Event Report: ARTHREX, INC. HD SCORPION NEEDLE (5 PACK); ORTHOPEDIC MANUAL SURG INSTR

Model Number	HD SCORPION NEEDLE (5 PACK)
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/29/2023, it was reported by a sales representative via sems-06044876 that an ar-13999hdn hd scorpion needle had an issue during a rotator cuff repair procedure on (b)(6) 2023.The new hd scorpion needle broke off in the cuff.The broken piece was not retrieved from the patient.The procedure was completed successfully.The complaint device was not available for return.This occurred during use with no patient harm.Additional information has been requested.On 10/12/2023, the sales representative provided the following information via email: another ar-13999hdn hd scorpion needle with an unknown lot number was used to complete the case successfully.There was very little to no case delay.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint allegation was confirmed upon evaluation of the customer attached picture.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause(s) for the reported failure can be a user error due to excessive force during use, misaligned insertion, and/or prying/levering the device.

• Brand Name: HD SCORPION NEEDLE (5 PACK)
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 18002253
• Report Number: 1220246-2023-08356
• Device Sequence Number: 17776777
• Product Code: LXH
• UDI-Device Identifier: 00888867374003
• UDI-Public: 00888867374003
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: HD SCORPION NEEDLE (5 PACK)
• Device Catalogue Number: AR-13999HDN
• Device Lot Number: 15055154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown