MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ANTERIOR TOTAL HIP CDS

Catalog Number	DYNJ907462G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, there have been multiple incidents where the suction tips are "coming apart" and the blue towels are "shedding lint and it is getting in the wound".The customer reported the issues are occurring before use and during use for both component issues.The customer reported after the incidents occur a new product/component is obtained to complete the procedure.The customer reported that there has been no impact on any patient or procedure related to the reported issues.No additional details are available related to the customer reported issue.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.
Event or Problem Description
According to the customer, there have been multiple incidents where the suction tips are "coming apart" and the blue towels are "shedding lint and it is getting in the wound".
Additional Manufacturer Narrative
Correction to d9: returned to manufacturer date.Update to h6: type of investigation.Update to h6: investigation findings.Update to h6: investigation conclusions.

• Common Device Name: ANTERIOR TOTAL HIP CDS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23040328
• Report Number: 1423395-2025-00121
• Device Sequence Number: 9889435
• Product Code: OJH
• UDI-Device Identifier: 10198459224393
• UDI-Public: 10198459224393
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 11/13/2025

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 Catalogue Number: DYNJ907462G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown