MAUDE Adverse Event Report: MEDLINE RENEWAL; 25-449-16-91 TWIST DRL,J-NOTCH W/20MM

Catalog Number	254491691RH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the report, the "drill broke" while the "resident" was drilling inside the patient's mouth.According to the report, an x-ray was performed in an attempt to locate the broken piece.To date, no information on the location of the broken piece or results of the x-ray have been obtained.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the report, the "drill broke" while the "resident" was drilling inside the patient's mouth.

• Common Device Name: 25-449-16-91 TWIST DRL,J-NOTCH W/20MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 94456 1876
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20533782
• Report Number: 3032391-2024-00007
• Device Sequence Number: 8325176
• Product Code: GFG
• UDI-Device Identifier: 10888277369405
• UDI-Public: 10888277369405
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 254491691RH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 112 KG