MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL DRILL, 4.0 MM; DRILL BIT

Model Number	HUMERAL DRILL, 4.0 MM
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
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 10/2/2023, it was reported by a sales representative via sems-06046630 that an ar-7720-3.5 humeral drill and an ar-7720-4.0 humeral drill, part of a rar-7700s ucl reconstruction set (loaner) had an issue.The 3.5 and 4.0 drills were just dull and smoking during the procedure.That happened during 3 cases in a row, and it was having the bone smoke more than normal.The set had been inspected upon receipt.This occurred during use in an unspecified procedure with no patient harm.Additional information has been requested.On (b)(6) 2023, the sales representative provided the following information via phone: the same ar-7720-3.5 humeral drill and an ar-7720-4.0 humeral drill, part of a rar-7700s ucl reconstruction set (loaner, with lot number 10225812) were used in three different collateral ligament repair procedures on (b)(6) 2023.The increased bone smoke did not burn or harm the patients, and there was no smoke or burning smell noticed by the surgeon or the facility staff during those cases.The three patients did not obtain any harm.The complaint devices were used to complete each procedure successfully.There were no case delays reported.
Additional Manufacturer Narrative
Complaint is confirmed.Visual inspection identified that the edges of the humeral drill, 4.0 mm had chipped and dulled.The laser marks faded.The most likely cause of this failure is attributed to wear and tear damage incurred over repeated usage.Dfu-0023-eo warns against using devices at section e.1.Arthrex non-sterile devices are precision medical devices and must be used and handled with care.Inspect the devices for damage prior to use and at all stages of handling thereafter.If damage is detected, do not use the device prior to consulting the manufacturer for guidance.Functional testing was not performed due to the dull condition of the device.

• Brand Name: HUMERAL DRILL, 4.0 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: emily shafer ; 8009337001
• MDR Report Key: 18030934
• Report Number: 1220246-2023-08445
• Device Sequence Number: 6074461
• Product Code: HTW
• UDI-Device Identifier: 00888867042162
• UDI-Public: 00888867042162
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/12/2024

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, 4.0 MM
• Device Catalogue Number: AR-7720-4.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/12/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown