MAUDE Adverse Event Report: ARTHREX, INC. FASTPASS SCORPION; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	FASTPASS SCORPION
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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.
Event or Problem Description
It was reported, that the tip of the ar-13997sf, scorpion broke off.The caller did not have additional information.Additional information 1/29/2021: it was reported by the sales rep that, the ar-13997sf, scorpion broke during a shoulder case.The surgeon felt it crack and it was removed from the surgery.The tip broke off in one piece and nothing was left in the patient.This did not affect the surgery.Another scorpion was opened and the case was completed.
Additional Manufacturer Narrative
The precise cause for a broken fastpass jaw at the trap door could not be determined.Broken fastpass jaw and mating needle were not returned along with the complaint device.Function test could not be performed due to the related condition.Unrelated condition, laser markings on the handle and the tip became rusted/discolored.

• Brand Name: FASTPASS SCORPION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11302940
• Report Number: 1220246-2021-02568
• Device Sequence Number: 883354
• Product Code: LXH
• UDI-Device Identifier: 00888867015982
• UDI-Public: 00888867015982
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FASTPASS SCORPION
• Device Catalogue Number: AR-13997SF
• Device Lot Number: 64400
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other