MAUDE Adverse Event Report: ARTHREX, INC. MULTIFIRE SCORPION NEEDLE; MANUAL INSTR, GENERAL SURGICAL

Model Number	MULTIFIRE SCORPION NEEDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a rotator cuff repair surgery the needle broke while suturing the tendon.The broken off part could not be retrieved from the patient.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 29-aug-2023 it was confirmed that the needle broke inside the patient and the broken part wasn¿t found.
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.
Additional Manufacturer Narrative
Additional information: h6.The complaint is not confirmed.No problem was found.One unpackaged ar-13995n-1, batch 15092825 was received for evaluation.Visual inspection found no broken parts/pieces on the device.Visual evaluation of the device picture attached to the complaint confirms that the received device is the same as in the image.A functional test with ar-13999mf batch 10574593 found no issues firing the needle.

• Brand Name: MULTIFIRE SCORPION NEEDLE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 17775620
• Report Number: 1220246-2023-07958
• Device Sequence Number: 20396352
• Product Code: MDM
• UDI-Device Identifier: 00888867283985
• UDI-Public: 00888867283985
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: MULTIFIRE SCORPION NEEDLE
• Device Catalogue Number: AR-13995N-1
• Device Lot Number: 15092825
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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