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

Model Number	SWIFTSTITCH HIP SUTURE PASSER
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/22/2025, it was reported by a sales representative via phone that (2) ar-3636h self bunching 1.8 knotless hip fibertak®soft anchors backed out, an ar-3638dhs-2 disposables kits handle bent, and an ar-4068hl swiftstitch¿ suture passer bent.This occurred during a hip arthroscopy on (b)(6) 2025 where additional ar-3636h was used, and a birdbeak was used to complete the case.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• 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: 21959301
• Report Number: 1220246-2025-01874
• Device Sequence Number: 15750299
• Product Code: LXH
• UDI-Device Identifier: 00888867300217
• UDI-Public: (01)00888867300217(11)240801(17)290731(10)4239152191
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/08/2025

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: 4239152191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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