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	Corroded (1131)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/13/2024, it was reported by a distributor via (b)(4) that an ar-12150 scissors were rusted and not cutting.This occurred during use.No additional information was provided.
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
Complaint allegation is confirmed.One unpackaged ar-12150 right curved tip scissors lot number: 10298090 was returned for investigation.Visual evaluation of the device noted rust and discoloration near the pins of the device as well as on the joint of the finger and thumb.The most likely cause for this failure can be attributed to environmental due to the cleaning process performed.Dfu-0255-eo warns against usage of low acid or alkaline solutions as they will corrode metal parts and anodized aluminum and compromise plastics.If non-neutral ph cleaning chemistries need to be used, neutralization steps should be taken so as not to negatively impact the fit, finish, or function of the device.Functional testing was performed by attempting to cut a suture and it was noted that the ar-12165 right curved tip scissors would not cut and had a lot of resistance when actuating.The most likely cause for this failure can be attributed to wear and tear.
Event or Problem Description
Additional information was provided on 05/16/2024 where it was stated during a shoulder surgery that was completed using another clamp.
Additional Manufacturer Narrative
Correction: e1.Additional information: b5, g3, h6.

• 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: 19496631
• Report Number: 1220246-2024-05346
• Device Sequence Number: 17807656
• 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,Followup
• Report Date (Section B): 11/18/2024

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: 10298090
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 05/16/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/18/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown