MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-TOTAL HIP

Catalog Number	DYNJG901013B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2025 the "drill bit broke while attempting to drill holes to repair capsule for posterior hip through bony tunnels" during a posterior total hip arthroplasty and was left in the patient.The customer reported "likely due to excessive torque from changing drill trajectory with tip of drill still in the bone.".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2025 the "drill bit broke while attempting to drill holes to repair capsule for posterior hip through bony tunnels" during a posterior total hip arthroplasty and was left in the patient.The customer reported "likely due to excessive torque from changing drill trajectory with tip of drill still in the bone." the customer said that the procedure was able to be completed.The customer reported there was no serious injury, medical intervention, or follow-up care required related to the reported incident.No additional information is available at this time.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.

• Common Device Name: DBD-TOTAL HIP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23646557
• Report Number: 1423395-2025-00194
• Device Sequence Number: 4769532
• Product Code: OJH
• UDI-Device Identifier: 10195327679132
• UDI-Public: 10195327679132
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/25/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: DYNJG901013B
• Device Lot Number: 25ELA302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 91 KG