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

Model Number	CAPSULECLOSE SCORPION
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/24/2021
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 during a hip scope procedure the surgeon was using the ar-16992 scorpion and a fiberwire to close the capsule.As they went to fire the needle to pass the suture through the tissue, the very tip of the scorpion broke off inside the joint while the needle remained intact.The surgeon was able to use a grasper and pull the piece of the scorpion out and there was no delay in the case.
Additional Manufacturer Narrative
The related condition is typically caused by applying too much force on thick tissue typically causes the tip to flex and the mating part (needle) to miss the needle slot on the tip of the device, rendering the device useless.The mating part (needle) was not returned along with the complaint device.Confirmed the capsuleclose scorpion suture clip 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: CAPSULECLOSE SCORPION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11655680
• Report Number: 1220246-2021-02896
• Device Sequence Number: 17201208
• Product Code: LXH
• UDI-Device Identifier: 00888867212688
• UDI-Public: 00888867212688
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/20/2021

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: CAPSULECLOSE SCORPION
• Device Catalogue Number: AR-16992
• Device Lot Number: 73798
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/20/2021
• Patient Sequence Number: 1