MAUDE Adverse Event Report: ARTHREX, INC. FASTPASS SCORPION-MULTIFIRE; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FASTPASS SCORPION-MULTIFIRE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
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 01/12/2024, it was reported by a sales representative via (b)(4) that an ar-13997mf scorpion broke during surgery.All fragments removed.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
The complaint allegation was confirmed.One unpacked ar-13997mf serial/batch number (b)(6) was received for investigation.Upon visual inspection, damage was observed at the tip, including nicks and scratches; additionally, half of the bottom jaw was missing, and the instrument exhibited significant wear and tear.The laser lines were also noticeably faded.No functional test was performed because of the damage to the instrument.The reported condition is most likely caused by user error overstressing a device that is damaged naturally and inevitably as a result of normal wear or aging.

• Brand Name: FASTPASS SCORPION-MULTIFIRE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18637502
• Report Number: 1220246-2024-00731
• Device Sequence Number: 7763455
• Product Code: LXH
• UDI-Device Identifier: 00888867015975
• UDI-Public: 00888867015975
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/18/2024

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: FASTPASS SCORPION-MULTIFIRE
• Device Catalogue Number: AR-13997MF
• Device Lot Number: 48007
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 02/04/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown