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

Model Number	SCORPION NEEDLE, KNEE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery it was found that the scorpion was blocked as prior to this event a needle broke off and remained stuck inside the device.There was no harm for patient, operator or third party reported.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.Update 26-jun-2024 dw: further information were provided that the needle broke during the same 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 was confirmed.One unpacked ar-12990n-1 serial/batch number (b)(6) was received for evaluation.The needled was received broken inside the ar-12990, batch 10474070.Visual evaluation of the ar-12990, batch 10474070 noted obstruction on the suture slot at the tip of the instrument, which is presumable to be the tip of the needle.No functional testing was performed because of a broken device inside the instrument.The most likely cause for the reported failure is a user error.Per dfu-03920-sub-eo, "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, KNEE
• 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: 19722311
• Report Number: 1220246-2024-06708
• Device Sequence Number: 18194595
• Product Code: LXH
• UDI-Device Identifier: 00888867266520
• UDI-Public: 00888867266520
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: SCORPION NEEDLE, KNEE
• Device Catalogue Number: AR-12990N-1
• Device Lot Number: 15101671
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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