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

Model Number SWIFTSTITCH HIP SUTURE PASSER

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On 11/17/2023, it was reported by a sales representative via email that an ar-3636h self bunching 1.8 knotless hip fibertak pulled out of the bone.The knotless hip fibertak was initially inserted using the 20-degree curved drill guide and the new 1.8 flexible fluted drill ar-3600nd-2hf.The anchor was inserted, and the repair suture was passed through the labrum.The repair stitch was converted into the anchor and tensioned down to pull the labrum up.When tensioning the repair suture, the anchor pulled out of the bone.Additionally, when using an ar-4068hl swiftstitch suture passer shredded the repair sutures upon passing through.The swiftstitch suture passer was switched for another one, and the procedure was continued without further issues.This was discovered during a hip labral repair procedure on (b)(6) 2023.Additional information received on 11/22/2023: the case was completed using another ar-3636h self bunching 1.8 knotless hip fibertak.The patient had normal bone quality.

• Brand Name: SWIFTSTITCH HIP SUTURE PASSER
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 18340577
• MDR Text Key: 331053033
• Report Number: 1220246-2023-09405
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867300217
• UDI-Public: 00888867300217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SWIFTSTITCH HIP SUTURE PASSER
• Device Catalogue Number: AR-4068HL
• Device Lot Number: 3240134552
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1