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	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip arthroscopy one device broke and a second device bent at the tip.The broken part was removed from the patient.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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation was confirmed.One unpackaged ar-4068hl swiftstitch¿ suture passer, hip length, crescent, batch 5195170509 was received for evaluation.During the visual inspection, it was noted that the nitinol wire lasso tip was broken off.The cannulated tip of the device was found to be bent, as well as the nitinol wire lasso.The device evaluation included measuring the cannula tip using drawing c12540, revision 1, and component c12540-01, revision 1.Radius (r):.31 ±.01 inches.Result:.52 inches.The tip was bent.A functional test was performed by extending/retracting the lasso without issues.The most likely cause of the reported failure is user error, including excessive force during insertion, striking the tip against bone with excessive force, or the device making contact with another instrument 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: 24258485
• Report Number: 1220246-2026-00405
• Device Sequence Number: 9513585
• 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): 03/13/2026

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
• Distributor Facility Aware Date: 01/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown