MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. DJO SURGICAL; BIT, DRILL

Model Number	803-15-008
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Djo surgical bayonet drill bit (part #803-15-008).At time of surgical preparation for cancellous bone screw during a total hip arthroplasty procedure, during normal use of the drill, the bit broke off while inside the patient.Per surgeon, multiple attempts to remove the broken drill bit were unsuccessful.He judged further attempts to remove the retained rill bit as having the potential for significant damage to the bone and decided to proceed with the surgery, leaving the retained drill bit in place.The recovered portion of the drill bit was measured at 15mm.Surgeon then estimated the length of the retained portion of the drill bit at 20mm.Surgeon anticipates no effects to patient of retained piece.

• Brand Name: DJO SURGICAL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 21546341
• Report Number: 21546341
• Device Sequence Number: 6987895
• Product Code: HTW
• UDI-Device Identifier: 00190446289265
• UDI-Public: (01)00190446289265(10)325184L02
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/19/2025
• Report Date (Section F): 02/19/2025

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: 803-15-008
• Device Lot Number: 325184L02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/19/2025