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

Catalog Number	DYNJ64924A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a patient was undergoing a left shoulder arthroscopy, debridement of capsule, glenoid labrum, rotator cuff repair, distal clavicle excision, and the blade broke into two pieces during the patient's procedure.Reportedly the blade was inserted into the shoulder, and was used to divide tissue from off of the humeral head.Downward force into the bone caused the blade to break in two.The surgeon reported that there was no unusual force placed on the blade outside of normal use.The facility reported that when the piece broke off of the blade the broken piece of the blade never left sight of the camera.The piece of the blade was retrieved with the grasper and removed immediately.The blade fragment was removed immediately, and the procedure continued as planned without further issue.There was no impact to the patient, or the procedure being performed.The patient was under anesthesia, however, no additional anesthesia, or medication was required.There was no report of any adverse patient consequence, and no effect on the patient's stability as a result of the incident.There were no complications noted with the patient during, or after the procedure.The actual device has been discarded, and is not available to be returned to medline for evaluation.No additional information is available.Due to the reported incident, and 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
It was reported that the surgical blade broke into two pieces, and was manually retrieved from the patient.

• Common Device Name: SHOULDER ARTHROSCOPY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10560478
• Report Number: 1423395-2020-00027
• Device Sequence Number: 1240843
• Product Code: OJH
• UDI-Device Identifier: 10193489303995
• UDI-Public: 10193489303995
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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: DYNJ64924A
• Device Lot Number: 20BBQ874
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/21/2020
• 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
• Patient Age: 64 YR
• Patient Weight: 95