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

Model Number	SCORPION NEEDLE, CAPSULECLOSE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic hip labral repair surgery the needle broke while trying to pass the repair suture through the hip capsule tissue.All parts were retrieved.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-16992n batch 15238319 was received for investigation.The visual inspection revealed that the needle's tip was broken off.Functional testing was not conducted due to the damage to the device.The most likely cause of the reported failure is a user error.Direction for use.Dfu-0392-sub-eo revision 1.To help avoid needle breakage and potential patient injury: do not resterilize 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: SCORPION NEEDLE, CAPSULECLOSE
• 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: 20311322
• Report Number: 1220246-2024-07865
• Device Sequence Number: 18090803
• Product Code: LXH
• UDI-Device Identifier: 00888867219557
• UDI-Public: (01)00888867219557(11)240423(17)290331(10)15238319
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: SCORPION NEEDLE, CAPSULECLOSE
• Device Catalogue Number: AR-16992N
• Device Lot Number: 15238319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2024
• 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