MAUDE Adverse Event Report: ARTHREX, INC. 2-0 SUTR CUTR,2.75 MM STR SFT; MANUAL INSTR, GENERAL SURGICAL

Model Number	2-0 SUTR CUTR,2.75 MM STR SFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The reported event was confirmed as the evaluation revealed that the tip pin is broken (see evaluation picture 3).Further the shaft is bent (see evaluation pictures 1 + 4).This is typically caused by applying excessive leveraging forces.Also the device shows signs of metal surface oxidation and the laser marks are faded (see evaluation pictures 1 - 5).
Event or Problem Description
It was reported that the mouth is broken off.There was no harm for the patient, operator or third party reported.No further information received.

• Brand Name: 2-0 SUTR CUTR,2.75 MM STR SFT
• 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: 19390347
• Report Number: 1220246-2024-03816
• Device Sequence Number: 18092571
• Product Code: MDM
• UDI-Device Identifier: 00888867003576
• UDI-Public: 00888867003576
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: 2-0 SUTR CUTR,2.75 MM STR SFT
• Device Catalogue Number: AR-11790
• Device Lot Number: 76155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown