MAUDE Adverse Event Report: ARTHREX, INC. SCISSORS, 3.4 MM, R CURVED, STR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SCISSORS, 3.4 MM, R CURVED, STR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
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.Complaint confirmed.Upon visual inspection, it was noted that the fixed jaw of the device was broken.The cause remains undetermined, although a probable cause is attributed to the application of leveraging forces on the distal end of the device.
Event or Problem Description
On 09/26/2022, it was reported by a distributor via sems that ar-12150 scissors clamp is broke.This was discovered on (b)(6) 2022 during an unknown case, with no patient effect reported.

• Brand Name: SCISSORS, 3.4 MM, R CURVED, STR
• 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: jared engle ; 8009337001
• MDR Report Key: 19463655
• Report Number: 1220246-2024-04884
• Device Sequence Number: 7998745
• Product Code: LXH
• UDI-Device Identifier: 00888867005228
• UDI-Public: 00888867005228
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• 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
• Report Date (Section B): 06/04/2024

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: SCISSORS, 3.4 MM, R CURVED, STR
• Device Catalogue Number: AR-12150
• Device Lot Number: 10282670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown