MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE UNITE; DRILL BIT, SOLID CORE, AO/QC, 1.9MM

Model Number	MPN10019
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility during a procedure the 'drill bit broke inside the patient and had to be removed by the physician'.The sample was not returned for evaluation.No additional information is available.Due to the reported incident and 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 facility during a procedure the 'drill bit broke inside the patient and had to be removed by the physician'.

• Brand Name: MEDLINE UNITE
• Common Device Name: DRILL BIT, SOLID CORE, AO/QC, 1.9MM
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14516621
• Report Number: 1417592-2022-00068
• Device Sequence Number: 20370861
• Product Code: HWC
• UDI-Device Identifier: 10888277690905
• UDI-Public: 10888277690905
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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 Model Number: MPN10019
• Device Catalogue Number: MPN10019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown