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	02/20/2024
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 02/21/2024, it was reported by a facility representative via email that an ar-13999hdn scorpion needle tip broke off.The piece remains inside the patient.This occurred during use in a case.Doctor elected to bypass x-ray confirmation of needle tip placement in patient as well as any surgical intervention as it would be more traumatic to attempt to remove it.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Visual inspection revealed that the needle of the hd scorpion needle had broken off and bent.Functional testing was not conducted due to the damage to the tip.The most likely cause of the reported failure is a use error.Per dfu-03920-sub-eo, to help avoid needle breakage and potential patient injury: do not re-sterilize or reuse the scorpion¿ suture passer needle.Avoid striking bone or using excessive force to pass the needle through fibrous/calcific tissue.If excessive force is encountered, replace the needle, reposition the device, and pass in a different area.Ensure a secure grasp of tissue to prevent the needle from buckling under the tissue.Avoid dry, repetitive actuations outside the surgical site.Abrasion of the needle surface can occur that may inhibit proper function.

• 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: jared engle ; 8009337001
• MDR Report Key: 18857962
• Report Number: 1220246-2024-01353
• Device Sequence Number: 15524489
• Product Code: LXH
• UDI-Device Identifier: 00888867374003
• UDI-Public: 00888867374003
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 15141378
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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