MAUDE Adverse Event Report: ARTHREX, INC. DYNANITE® STAPLE DRL BT, CAL, 2.6, REUSE; DRILL BIT

Model Number	DYNANITE® STAPLE DRILL BIT, CAL, 2.6
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the doctor drilled using an ar-8717g-03 drill guide and ar-8717d-03-ru drill bit, the thick part and sleeve locked on the drill shaft and it would not move.Bone fragments were removed, but the problem of the thick part of the drill shaft not being able to pass through, was not resolved.A new product was used and the case was completed.No adverse effect to the patient reported.
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.Complaint confirmed.There is clear damage on the od of the drill bit shaft, proximal to the flutes.The visible wear on both the od of the drill bit shaft and the id of one drill guide hole indicates contact between the two surfaces while the drill was in use.The non-worn region of the drill bit shaft appears to have an acceptable od, while the worn region has clear frays and exceeds the od limits set by the drawing.It is unclear what caused the drill bit to interface with the id of the one drill hole on ar-8717g-03.The most likely cause for the reported failure can be attributed to user error of the device due to tissue obstruction reducing the drill hole id, or improper drill alignment by the user.

• Brand Name: DYNANITE® STAPLE DRL BT, CAL, 2.6, REUSE
• 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: 19333034
• Report Number: 1220246-2024-03421
• Device Sequence Number: 3063192
• Product Code: HTW
• UDI-Device Identifier: 00888867326187
• UDI-Public: 00888867326187
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: DYNANITE® STAPLE DRILL BIT, CAL, 2.6
• Device Catalogue Number: AR-8717D-03-RU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown