MAUDE Adverse Event Report: ARTHREX, INC. AVL 4.5MM INFERIOR DRILL, MODULAR; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	AVL 4.5MM INFERIOR DRILL, MODULAR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/08/2022, it was reported by a sales representative via sems that a ar-9239ag inferior drill, and a ar-9231-vl-01 drill guide didn't hold up under the torque it received, and both devices broke.This occurred during a case, another tray was used to complete the case.There was no patient effect reported.
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 12/08/2022, it was reported by a sales representative via sems that a ar-9239ag inferior drill, and a ar-9231-vl-01 drill guide didn't hold up under the torque it received, and both devices broke.This occurred during a case, another tray was used to complete the case.There was no patient effect reported.Additional information provided on 12/13/2022, it was reported that this event occurred on 12/06/2022 during a total shoulder case.All metal shavings were retrieved.
Additional Manufacturer Narrative
Complaint is confirmed.Upon visual evaluation, it was noted that the drill flutes are damaged with abrasion marks and nicks, around the outside diameter of the device was observed strong abrasion marks.The spring coil is missing.The most likely cause is that the drill was activated when it went in/out through the drill guide.The cause remains misuse.

• Brand Name: AVL 4.5MM INFERIOR DRILL, MODULAR
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16052032
• Report Number: 1220246-2022-05994
• Device Sequence Number: 15007486
• Product Code: HWE
• UDI-Device Identifier: 00888867350489
• UDI-Public: 00888867350489
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/02/2023

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: AVL 4.5MM INFERIOR DRILL, MODULAR
• Device Catalogue Number: AR-9239AG
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 05/02/2023
• 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