MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL DRILL, 2.0 MM; DRILL BIT

Model Number	HUMERAL DRILL, 2.0 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 5/31/2024, a sales representative reported via (b)(4) that an ar-7720-2.0 humeral drill (from a loaner set rar-7700s-in, (b)(6)) broke off in the humeral epicondyle.The broken piece was visible and easily retrieved with no case delay.It was stated that the drill was oscillated which could have contributed to breakage of the drill bit.The case was continued utilizing the 3.5 mm drill bit, and it was completed with no issues.This was discovered during an elbow ucl reconstruction procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged, ar-7720-2.0, humeral drill, was received for investigation.Visual inspection found that the flute broke off at the proximal thread.Some circumferential grinding marks can be observed along the shaft.Laser etchings appear discolored as well.Functional testing could not be performed due to the damage of the device.The most likely cause for the reported failure can be attributed to use error of the device due to prying/leveraging the device during use.Per dfu-0023-eo; revision 4: 6.Flexion of the joint with the instrument in position in the joint may result in bending or breakage of the instrument.7.Do not overstress the device or use device to pry tissue.

• Brand Name: HUMERAL DRILL, 2.0 MM
• 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: 19606680
• Report Number: 1220246-2024-06412
• Device Sequence Number: 18173084
• Product Code: HTW
• UDI-Device Identifier: 00888867042124
• UDI-Public: 00888867042124
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 09/20/2024

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: HUMERAL DRILL, 2.0 MM
• Device Catalogue Number: AR-7720-2.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown