MAUDE Adverse Event Report: ARTHREX, INC. 3.0 KNOTLESS HIP SUTURETAK DISP DRILL HB; DRILL BIT

Model Number	3.0 KNOTLESS HIP SUTURETAK DISP DRILL HB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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 08/15/2025, it was reported by a sales representative via (b)(4) that an ar-1938dhd knotless hip suturetak disp.Drill hb experienced a malfunction.During a hip arthroscopy procedure, while the surgeon was drilling directly into the bone without applying any side-to-side torque or tweaking motion, metallic fragments were observed emerging from the drill bit.It was confirmed that the standard technique was followed and the occurrence was unexpected.This was discovered during the case.Another device was used to complete the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: 3.0 KNOTLESS HIP SUTURETAK DISP DRILL HB
• Common Device Name: DRILL BIT
• 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: 22964717
• Report Number: 1220246-2025-03734
• Device Sequence Number: 18455944
• Product Code: HTW
• UDI-Device Identifier: 00888867253933
• UDI-Public: (01)00888867253933(11)250505(17)300430(10)15431390
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/17/2025

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: 3.0 KNOTLESS HIP SUTURETAK DISP DRILL HB
• Device Catalogue Number: AR-1938DHD
• Device Lot Number: 15431390
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown