MAUDE Adverse Event Report: ARTHREX, INC. SC, 4.2 OPN ENDD, LFT NTCH, W/FLUSHPORT; MANUAL INSTR, GENERAL SURGICAL

Model Number	SC, 4.2 OPN ENDD, LFT NTCH, W/FLUSHPORT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy the device broke during use and the closing mechanism was defective.The surgeon had to cut the sutures with scissors.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.
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
The complaint allegation is confirmed.One unpackaged ar-11794lf suture cutter with lot number: 15140485 was received for investigation.Visual evaluation of the device noted no problems with the exterior of the device.Functional testing was performed by attempting to cut a suture and it was noted that the ar-11794lf suture cutter would not cut and the actuator would not open and close the jaw as expected.The most likely cause for the reported failure can be attributed to wear and tear incurred from repeated usage.Refer to investigation photos.

• Brand Name: SC, 4.2 OPN ENDD, LFT NTCH, W/FLUSHPORT
• 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: jared engle ; 8009337001
• MDR Report Key: 19285551
• Report Number: 1220246-2024-03076
• Device Sequence Number: 8474064
• Product Code: MDM
• UDI-Device Identifier: 00888867252448
• UDI-Public: 00888867252448
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/19/2024

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: SC, 4.2 OPN ENDD, LFT NTCH, W/FLUSHPORT
• Device Catalogue Number: AR-11794LF
• Device Lot Number: 15140485
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown