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

Catalog Number	DYNJ84843B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on 3/6 for a knee scope, "the surgeon made the nincisions for his knee scope case.On his last incision, the #11 blase came off of the blade handle.The surgeon was able to retrieve the blade but during the retrieval, the tip of the blade broke off.".
Additional Manufacturer Narrative
According to the facility on 3/6 for a knee scope, "the surgeon made the incisions for his knee scope case.On his last incision, the #11 blade came off of the blade handle.The surgeon was able to retrieve the blade but during the retrieval, the tip of the blade broke off.Xray was taken to show the residual broken piece.The piece was on the medial side of the knee.The surgeon was able to find the broken piece and remove it successfully.I visually witnessed him remove the piece and the broken piece was visibly intact.The surgeon took an xray and the piece was clearly gone".The facility stated they used xray and laparoscopic instruments to remove the broken blade piece from medial side of the knee.The procedure took an extra 45 minutes to complete and had to utilize xray.The facility stated there was no impact to that patient and no serious injury.The device 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.

• Common Device Name: KNEE ARTHROSCOPY PACK
• 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: 21778140
• Report Number: 1423395-2025-00031
• Device Sequence Number: 12920630
• Product Code: LRO
• UDI-Device Identifier: 10195327599782
• UDI-Public: 10195327599782
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/04/2025

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
• Device Catalogue Number: DYNJ84843B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 04/04/2025
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 102 KG