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

Model Number	HD SCORPION NEEDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
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 6/12/2024, it was reported by a sales representative via sems-(b)(4) that (qty.2) of an ar-13999hdn hd scorpion needle had an issue when passing through the scorpion multi fire handle; it would become stuck and had another needle tip break off.All pieces were recovered from the patient.The case was completed with another ar-13999hdn hd scorpion needle and scorpion.No adverse effects were reported on the patient.This was discovered during a procedure, with no reported patient harm.Additional information received on 6/18/2024: there was no additional steps added or anesthesia or delay.This occurred on (b)(6) 2024 during a shoulder arthroscopy procedure.
Additional Manufacturer Narrative
The complaint allegation is not confirmed.One sealed packaged ar-13999hdn serial/batch number (b)(6) was received for investigation.Functional testing involving a scorpion suture passer, and a suture revealed no issues with the returned needle.The instrument was activated, and the needle grasped the suture without any problems.Visual inspection confirmed that the needle is in perfect condition with no issues or defects detected.No problem found.

• Brand Name: HD SCORPION NEEDLE
• 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: jared engle ; 8009337001
• MDR Report Key: 19689975
• Report Number: 1220246-2024-06622
• Device Sequence Number: 8066851
• Product Code: LXH
• UDI-Device Identifier: 00888867374003
• UDI-Public: 00888867374003
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 09/25/2024

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
• Device Catalogue Number: AR-13999HDN
• Device Lot Number: 15217507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2024
• 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