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	07/09/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a hip arthroscopic procedure, when the surgeon was attempting to pass a #2 fiberwire with the capsule close scorpion, ar-16992, the tip of the instrument broke into 3 pieces in the joint.The surgeon was able to retrieve the 3 broken pieces from the joint and follow up x-rays were taken to ensure nothing was missed.The case was completed by using another scorpion.
Additional Manufacturer Narrative
The device was not returned for evaluation, however pictures of the complaint device were provided.Review of the pictures shows that the capsuleclose scropion suture clip spring (part number 910-021), 2.75mm shear pin (part number 118-204) and capsuleclose scorpion suture clip (part number 910-019) broke off the distal end of the device.As the device was not returned for investigation, the cause of the breakage could not be determined.

• 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: 12231919
• Report Number: 1220246-2021-03447
• Device Sequence Number: 4991533
• Product Code: LXH
• UDI-Device Identifier: 00888867212688
• UDI-Public: 00888867212688
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/01/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1