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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
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 (b)(6) 2023, it was reported by a distributor via sems that an ar-12150 scissors clamp broke.This occurred during a procedure on.There was no additional information provided, additional information has been requested.
Additional Manufacturer Narrative
The complaint allegation was confirmed.(1) unpackaged ar-12150 scissor right curve tip was returned for investigation.The returned device was visually inspected, and it was noted that there was contamination on the scissor tip in the washer between the thumb and finger.No broken pieces were identified during the inspection.Upon functional testing, it was noted that the scissor does not open/close smoothly.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17452468
• Report Number: 1220246-2023-07408
• Device Sequence Number: 12608276
• 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: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: SCISSORS, 3.4 MM, R CURVED, STR
• Device Catalogue Number: AR-12150
• Device Lot Number: 13395167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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