MAUDE Adverse Event Report: ARTHREX, INC. DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM; ORTHOPEDIC MANUAL SURG INSTR

Model Number	DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2024
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
On (b)(6) 2024, it was reported by a sales representative via (b)(4) that an ar-3638dhc-2 disposables kits drill bit broke.This occurred during a hip scope/labral repair on thursday (b)(6) 2024.They used a 1.8 hip knotless fibertaks, and were drilling for the third anchor, using the curved disposable kit ar-3638dhc-2, when the drill bit broke and resulted in two hours of searching for it, finding, and extracting the broken drill bit tip.The surgeon and his pa did not feel the drill bit skive, yet the broken tip was found in soft tissue, not bone.
Event or Problem Description
Additional information was provided on 10/03/2024 where the sales representative stated that this event occurred on 10/26/2024 during a hip labral repair, the drill bit broke while drilling for the 3rd anchor in the repair.The surgeon believes it may have skived off the acetabulum, but neither the surgeon nor pa felt or heard anything unusual while drilling.The patient had hard bone per the surgeon.An ar-3638dhc-2; 1.9 drill bit and curved guide were used to prepare the bone for insertion.The broken drill bit fragment was eventually found in soft tissue, once the broken drill bit fragment was removed, the surgeon did not proceed with re-drilling and inserting the 3rd anchor.The case took an additional 2 hours to find and retrieve the drill bit fragment which required additional anesthesia.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-3638dhc-2, batch 15211613 was received for investigation.Upon visual evaluation, it was noted that the fluted nitinol drill had a broken tip.Functional test was not performed due to the damage of the device.The most likely cause can be attributed to improper bone preparation; misaligned insertion; or prying/leveraging the device during use.Per the surgical technique (labral base mattress stitch configuration; section #1): "create a bone socket by sliding the appropriate drill guide down the cannula and placing it on the acetabular rim near the articular surface.Advance the drill bit on power through the drill guide until the collar contacts the handle.Note: drilling in very hard bone may require cycling the drill while maintaining consistent alignment of the drill guide.Larger hard bone drills are also available.".

• Brand Name: DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
• 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: 20472877
• Report Number: 1220246-2024-08190
• Device Sequence Number: 7603759
• Product Code: LXH
• UDI-Device Identifier: 00888867430044
• UDI-Public: (01)00888867430044(11)240223(17)290131(10)15211613
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/20/2024

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: DISP,CURVED KIT, KNOTLESS HIP FTAK 1.9MM
• Device Catalogue Number: AR-3638DHC-2
• Device Lot Number: 15211613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2024
• 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