MAUDE Adverse Event Report: ARTHREX, INC. SWIFTSTITCH HIP SUTURE PASSER; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SWIFTSTITCH HIP SUTURE PASSER
Medical Device Problem Codes	Use of Device Problem (1670); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via email that an ar-4068hl swiftstitch suture passer frayed the suture.This was discovered during a procedure.Additional information received on 9/19/2024: this was discovered during a hip arthroscopy labral repair procedure on 9/12/2024.The swiftstitch suture passer frayed an ar-7216 fiberwire, which broke.Everything was removed from inside the patient.The case was completed using products from another manufacturer.It was delayed about two minutes without additional anesthesia.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted the suture had frayed.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error due to excessive force/friction during use or insertion.

• Brand Name: SWIFTSTITCH HIP SUTURE PASSER
• 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: 20408358
• Report Number: 1220246-2024-08043
• Device Sequence Number: 15089528
• Product Code: LXH
• UDI-Device Identifier: 00888867300217
• UDI-Public: (01)00888867300217(11)230901(17)280831(10)3240134552
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/21/2025

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: SWIFTSTITCH HIP SUTURE PASSER
• Device Catalogue Number: AR-4068HL
• Device Lot Number: 3240134552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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