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	11/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 it was reported by a sales representative via (b)(6) that an ar-13997sf, fastpass scorpion piece is broken.This was discovered during use in a procedure.No patient affect reported.There was no additional information provided.Requested additional information.
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.
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 (b)(6) 2021 it was reported by a sales representative via (b)(6) that an ar-13997sf, fastpass scorpion piece is broken.This was discovered during use in a procedure.No patient affect reported.There was no additional information provided.Requested additional information.
Additional Manufacturer Narrative
Complaint not confirmed.Visual evaluation showed no broken pieces.Laser markings on the device were rusted/discolored.During device functioning a new ar-13991n needle was used, showing no issues with the device.Device work as intended.

• Brand Name: FASTPASS SCORPION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 12984970
• Report Number: 1220246-2021-04114
• Device Sequence Number: 17321325
• Product Code: LXH
• UDI-Device Identifier: 00888867015982
• UDI-Public: 00888867015982
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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
• Device Catalogue Number: AR-13997SF
• Device Lot Number: 48293
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown