MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT FOR 3.5MM SWIVELOCK

Model Number	DRILL BIT FOR 3.5MM SWIVELOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
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.The product was not returned for investigation, however a picture was provided of a drill bit inserted into a drill guide.From the picture it can be seen that the distal end of the drill bit which is protruding out of the distal end of the drill guide is bent.From the picture the part and lot numbers are not visible.As the device was not returned, no further investigation was able to be performed into what led to the device becoming bent.The most likely cause(s) for the reported failure is prying/leveraging the device against bone or another instrument.
Event or Problem Description
A drill bit was damaged in theatre.The nature of the damage: bent at the tip, still intact, no loose fragments.It was safely removed from the patient without causing harm.

• Brand Name: DRILL BIT FOR 3.5MM SWIVELOCK
• 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: 19391151
• Report Number: 1220246-2024-03834
• Device Sequence Number: 15391862
• Product Code: HTW
• UDI-Device Identifier: 00888867020863
• UDI-Public: 00888867020863
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: DRILL BIT FOR 3.5MM SWIVELOCK
• Device Catalogue Number: AR-1678-05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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