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	10/12/2020
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 during a shoulder arthroscopic procedure, the surgeon was performing the speed bridge technique on the rotator sleeve, the tip of the ar-13997sf, was blocked.Additional information provided on 10/21/2020: it was reported that the clamp would no longer open after clamping the rotator cuff.The surgeon would have to open the clamp several times in order to get it to unlock.The surgeon had to switch from a speed bridge technique during the surgery, to a double row technique, in order to complete the case.The devices used to completed the case are as follows: ar-2324; ar-7237; ar-7200.
Additional Manufacturer Narrative
The precise cause for the related condition could not be determined.The mating part (needle) was not returned along with the complaint device.Function test could not be performed due to the related condition.Broken tip pin was not returned along with complaint device.

• 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: 10785728
• Report Number: 1220246-2020-02308
• Device Sequence Number: 2938265
• Product Code: LXH
• UDI-Device Identifier: 00888867015982
• UDI-Public: 00888867015982
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: FASTPASS SCORPION
• Device Catalogue Number: AR-13997SF
• Device Lot Number: 87730C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other