MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; KNEE ARTHROSCOPY I

Catalog Number	DYNJ08333
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 it was noted that the "tip of the blade was broken off" after "two puncture incisions were made".The customer reported an xray showed the part of the blade that had broken off "was inside the patient's soft tissue".The customer reported the surgeon used "fluoroscopy guidance and a hemostat" to locate the retained piece, "another surgical blade" was used to "extend" the incision closest to the retained piece, and the piece was extracted.The customer reported after the retained piece was extracted the incisions were closed and dressings were placed.The customer reported the retained piece was disposed of in a "sharps container".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, on (b)(6) 2024 it was noted that the "tip of the blade was broken off" after "two puncture incisions were made".
Additional Manufacturer Narrative
Update h6- investigation conclusions.

• Common Device Name: KNEE ARTHROSCOPY I
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19004684
• Report Number: 1423395-2024-00377
• Device Sequence Number: 8501951
• Product Code: OJH
• UDI-Device Identifier: 40080196861485
• UDI-Public: 40080196861485
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/24/2024

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: DYNJ08333
• Device Lot Number: 23JBO296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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