MAUDE Adverse Event Report: 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM; BIT, DRILL

Model Number	03.010.078
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on an unknown date, during the insertion of a femoral nail, a drill bit broke off in the patient's femoral neck and was unable to be removed.A 20mm drill bit segment was left in the femoral head.The procedure was successfully completed with twenty minutes surgical delay.Patient status is unknown.Concomitant device: unknown femoral nail (part# unknown, lot# unknown, quantity 1).This report is for (1) 4.5mm/6.5mm stepped drill bit large qc/485mm.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM
• Common Device Name: BIT, DRILL
• MDR Report Key: 12727927
• Report Number: 2939274-2021-06386
• Device Sequence Number: 1559084
• Product Code: HTW
• UDI-Device Identifier: 10886982067487
• UDI-Public: 10886982067487
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.010.078
• Device Catalogue Number: 03.010.078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 11/01/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS: FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR