MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM MGS DRILL BIT, STERILE; POWERED SURG ORTHOPEDIC INSTR

Model Number	3.0MM MGS DRILL BIT, STERILE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
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 05/09/2023, it was reported by a sales representative via sems that an ar-9628s drill bit broke off.This was discovered during a case, device breaks during use.Per facility: "the surgeon was drilling for a non-locking peripheral screw and believes he hit the posterior retractor, in which the tip ended up breaking off.After the baseplate was removed, he was able to retrieve the broken piece.".
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to hitting the device against another device.

• Brand Name: 3.0MM MGS DRILL BIT, STERILE
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 17054431
• Report Number: 1220246-2023-06833
• Device Sequence Number: 6984384
• Product Code: HWE
• UDI-Device Identifier: 00888867350571
• UDI-Public: 00888867350571
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 10/16/2024

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: 3.0MM MGS DRILL BIT, STERILE
• Device Catalogue Number: AR-9628S
• Device Lot Number: 15060713
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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