MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TPLO PACK

Catalog Number	DYNJ87591
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, for the last "4-6 weeks" the gauze is "shedding threads" into the surgical incisions and on the end table while "absorbing fluid in a surgical incision".
Additional Manufacturer Narrative
According to the customer, for the last "4-6 weeks" the gauze is "shedding threads" into the surgical incisions and on the end table while "absorbing fluid in a surgical incision".The customer reported that "more anesthesia time" is required while the surgical site is cleared of foreign material.The customer reported the procedures were all able to be completed.No additional details are available related to the customer reported issue.The customer reported there was no serious injury 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.
Additional Manufacturer Narrative
Update to d9: sample returned.Update to h3: sample evaluated.Update to h6: type of investigation.Update to h6: investigation findings.Update to h6: investigation conclusions.

• Common Device Name: TPLO PACK
• 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: 23040322
• Report Number: 1423395-2025-00122
• Device Sequence Number: 18614280
• Product Code: LRO
• UDI-Device Identifier: 10198459046513
• UDI-Public: 10198459046513
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/03/2025

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: DYNJ87591
• Device Lot Number: 25CBE884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/06/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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 Sex: Unknown