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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
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
It was reported that during an arthroscopic hip surgery the front part of the device got bent and could no longer be used without breaking off.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-4068hl swiftstitch¿ suture passer, batch 5195170509, was received for investigation.Visual evaluation noted that the jaw was fractured at the tip.Functional testing was not performed due to the inability to grasp the suture.The most likely cause of the reported failure is user-related factors, such as prying or applying excessive mechanical force to the device.The complaint allegation is not confirmed.Refer to the investigation photos.

• 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: 24413635
• Report Number: 1220246-2026-00859
• Device Sequence Number: 12231843
• Product Code: LXH
• UDI-Device Identifier: 00888867300217
• UDI-Public: (01)00888867300217(11)250801(17)300731(10)5195170509
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: 5195170509
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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