MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TOTAL KNEE PACK-LF

Catalog Number DYNJ69123C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/09/2024

Event Type  Injury  

Manufacturer Narrative

According to the facility on (b)(6) 2024 "the cautery tip broke during (the) surgical case, tip was removed from surgical field".Per the facility the tip broke off inside the patient and was removed after the incident was observed.Per the facility there was no known injury to the patient.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 Description

According to the facility on (b)(6) 2024 the cautery tip broke during (the) surgical case, tip was removed from surgical field".

• Type of Device: TOTAL KNEE PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18874391
• MDR Text Key: 337316525
• Report Number: 1423395-2024-00343
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10195327357382
• UDI-Public: 10195327357382
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ69123C
• Device Lot Number: 23CMC978
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other