MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ARTHROSCOPY PACK

Catalog Number	DYNJ52969B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that an eleven blade out of an arthroscopy kit broke during a right knee procedure.The incident occurred at the start of the procedure.The facility reported that the blade was gently placed on the skin in order to cut and the blade broke in two pieces just above the knife handle.One piece fell off inside the patient however the surgeon was able to be manually remove the full blade piece without incident or injury.The actual sample was not returned to the manufacturer for evaluation, however a photo was received and the customer reported issue was confirmed.Upon photo evaluation it was noted that the tip of the blade was broken in two pieces.Upon further inspection it was seen that the blade broke right near the connection point to the reusable handle.A root cause could not be determined at this time.No serious injury or follow up medical care was reported related to the customer reported issue.There was no report of any adverse patient consequence, no effect on the patient's stability, and no medical intervention required as a result of the incident.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that an eleven blade out of an arthroscopy kit broke during a right knee procedure requiring manual removal during surgery.

• Common Device Name: ARTHROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11738653
• Report Number: 1423395-2021-00024
• Device Sequence Number: 19791669
• Product Code: OJH
• UDI-Device Identifier: 10193489336627
• UDI-Public: 10193489336627
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ52969B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention