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

Model Number	SCISSORS, 3.4 MM, L CURVED, STR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/2/2023, it was reported by a distributor via sems-06046857 that an ar-12160 scissors caliper is broken.This was discovered during an unspecified procedure on (b)(6) 2023, with no reported patient harm.Additional information received on 10/3/2024: ar-12160 scissors broke at the tip.The device did not break inside the patient.The case was completed using another clamp.This was discovered during a shoulder scope procedure on (b)(6) 2023, with no reported adverse event or patient harm.
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
Additional information: d9, g3, h6.Complaint allegation is confirmed.Functional testing was not performed on the returned ar-12160 due to the damage to the device.Visual inspection noted the tip of the scissors is broken.The most likely cause for the reported failure can be attributed to use error due to excessive user-applied mechanical forces.Refer to the investigation photos.

• Brand Name: SCISSORS, 3.4 MM, L 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: 18039292
• Report Number: 1220246-2023-08465
• Device Sequence Number: 15336171
• Product Code: LXH
• UDI-Device Identifier: 00888867005266
• UDI-Public: 00888867005266
• 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): 06/20/2024

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, L CURVED, STR
• Device Catalogue Number: AR-12160
• Device Lot Number: 78332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• 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