MAUDE Adverse Event Report: ARTHREX, INC. DRL BIT, 3.2MM, CANN., LONG; DRILL BIT

Model Number	DRL BIT, 3.2MM, CANN., LONG
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/16/2022 it was reported by a sales representative via sems that the ar-8750-09, ar-8770-02, ar-8750k, and ar-8770k kwires of the 5.0/7.0 keep getting stuck in the drill bits and pulling out of the patient, therefore losing the surgeons kwire positioning.No patient affect.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.However, due to the device being returned unpackaged, we are unable to confirm the reported event.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).

• Brand Name: DRL BIT, 3.2MM, CANN., LONG
• 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: 19476700
• Report Number: 1220246-2024-05052
• Device Sequence Number: 19828920
• Product Code: HTW
• UDI-Device Identifier: 00888867266056
• UDI-Public: 00888867266056
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 06/06/2024

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: DRL BIT, 3.2MM, CANN., LONG
• Device Catalogue Number: AR-8750-09
• Device Lot Number: 032219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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