MAUDE Adverse Event Report: ARTHREX, INC. CAPSULECLOSE SCORPION; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CAPSULECLOSE SCORPION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	04/26/2023
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
On 04/26/2023, it was reported by a sales representative via sems that an ar-16992 capsuleclose scorpion needle broke off.This was discovered during a case and device broke during use.Per facility: "when closing the capsule in the hip the doctor closed the scorpion and fired the needle through the capsule and the suture didn't pass.When he pulled the scorpion out of the portal the tip was broken off the scorpion.Picture is attached.I was in the case and asked him if he squeezed the device extremely hard and he said no.".
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-16992 serial/batch number (b)(6) was received for investigation.No functional testing for the instrument was performed due to the tip damage.Visual evaluation noted that the tip of the scorpion was broken.It was observed that the flushport luer lock was damaged and moved from the original position.The most likely cause can be attributed to abnormal use.

• Brand Name: CAPSULECLOSE SCORPION
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 16939112
• Report Number: 1220246-2023-06757
• Device Sequence Number: 6017780
• Product Code: LXH
• UDI-Device Identifier: 00888867212688
• UDI-Public: 00888867212688
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 07/21/2023

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: 15037364
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown