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

Model Number	FASTPASS SCORPION
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is now reportable.During returned device evaluation, a reportable malfunction was discovered.The precise cause for the broken moving jaw near the trap door pin could not be determined.The mating part (needle) or the broken jaw were not returned along with the complaint device.Confirmed the fastpass jaw heat treat reading to be within hardness specification.Device history record review revealed nothing relevant to this event.Function test could not be performed due to the related condition.
Event or Problem Description
It was reported that during a shoulder arthroscopic procedure, the ar-13997sf, would not grasp correctly as it was locked.The case was completed by using another ar-13997sf without further issue.This is now reportable.During returned device evaluation, a reportable malfunction was discovered.The precise cause for the broken moving jaw near the trap door pin could not be determined.The mating part (needle) or the broken jaw were not returned along with the complaint device.Confirmed the fastpass jaw heat treat reading to be within hardness specification.Device history record review revealed nothing relevant to this event.Function test could not be performed due to the related condition.
Additional Manufacturer Narrative
The precise cause for the broken moving jaw near the trap door pin could not be determined.The mating part (needle) or the broken jaw were not returned along with the complaint device.Confirmed the fastpass jaw heat treat reading to be within hardness specification.Device history record review revealed nothing relevant to this event.Function test could not be performed due to the related condition.

• 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: 11761593
• Report Number: 1220246-2021-03007
• Device Sequence Number: 19837473
• 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: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 67416
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/05/2021
• Patient Sequence Number: 1