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

Model Number	HD SCORPION NEEDLE (5 PACK)
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 11/30/2023, it was reported by a sales representative via (b)(4) that an ar-13999hdn hd scorpion needle tip broke off and was never located.It is not known if it fell inside the patient or not.A second ar-13999hdn hd scorpion needle was brought in and the packaging was noticed not to be completely sealed, but it was never close to the field.A third ar-13999hdn hd scorpion needle was used to complete the case.This was discovered during an unspecified procedure.
Additional Manufacturer Narrative
Additional information: complaint allegation was not confirmed.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 attributed to mishandling the device.
Event or Problem Description
Additional information was received on 3/15/2024: the case was delayed a very brief time to replace the scorpion needle and several minutes searching for the needle tip and bringing c-arm in to x-ray without adverse effects on the patient reported.An x-ray was performed and nothing was found.This was discovered during a arthroscopic rcr procedure on (b)(6) 2024.

• Brand Name: HD SCORPION NEEDLE (5 PACK)
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18399426
• Report Number: 1220246-2023-09657
• Device Sequence Number: 2760006
• Product Code: LXH
• UDI-Device Identifier: 00888867374003
• UDI-Public: 00888867374003
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/08/2025

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: 15153997
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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