MAUDE Adverse Event Report: ARTHREX, INC. SMALL FIBERWIRE SUTURE SCISSORS; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SMALL FIBERWIRE SUTURE SCISSORS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 06/26/2024, it was reported by a sales representative via (b)(4) that an ar-11797 fiberwire suture scissor blade broke in half during a case while attempting to cut fiberwire suture.Photos are attached of the complaint device.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-11797 serial/batch number (b)(6) was received for investigation.Functional testing was not performed as the device was broken.Visual inspection revealed that the instrument was broken was broken.The finger was detached from the jaws at the pin.The reported condition is likely a result of excessive force applied during use.
Event or Problem Description
Additional information was received on 7/19/2024: this was discovered during a thumb ucl ib procedure.The case was completed by cutting the fiberwire with a blade already open on the field instead of scissors.No pieces broke off into the patient, and all pieces were retrieved and will be returned.No adverse effects occurred.

• Brand Name: SMALL FIBERWIRE SUTURE SCISSORS
• 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: 19793292
• Report Number: 1220246-2024-06843
• Device Sequence Number: 14502680
• Product Code: LXH
• UDI-Device Identifier: 00888867003620
• UDI-Public: 00888867003620
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/30/2024

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: SMALL FIBERWIRE SUTURE SCISSORS
• Device Catalogue Number: AR-11797
• Device Lot Number: 4555214708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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