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

Catalog Number	DYNJ905847K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, during a right total hip arthroplasty on (b)(6) 2025, while the physician was suctioning out the femoral canal, approximately 4.5cm of the suction tip broke off and entered the femoral canal.The physician could not retrieve the device and felt it was in the patient's best interest to leave the object in as further attempts or removal were deemed to pose a greater risk of injury and structural compromise.The device was being used to suction out the femoral canal."no serious injury was identified".There was no impact to the procedure, and the procedure was completed.The patient followed up postoperatively with the operating physician.A sample is not available for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, 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 right total hip arthroplasty on (b)(6) 2025, while the physician was suctioning out the femoral canal, approximately 4.5cm of the suction tip broke off and entered the femoral canal.

• Brand Name: MEDLINE
• Common Device Name: DBD-TOTAL HIP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 24240440
• Report Number: 1423395-2026-00017
• Device Sequence Number: 21376134
• Product Code: OJH
• UDI-Device Identifier: 10195327633295
• UDI-Public: 10195327633295
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/02/2026

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
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: DYNJ905847K
• Device Lot Number: 24LBL128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2024
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 86 KG