MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. - SPT TOTAL KNEE [PACK]; ORTHOPEDIC TRAY

Model Number CMPJ05911

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Medline total knee procedure pack with hole in sterile table cover.Outside clear, protective cover intact.Fda safety report id# (b)(4).

• Brand Name: TOTAL KNEE [PACK]
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. - SPT
• MDR Report Key: 11812094
• MDR Text Key: 250399098
• Report Number: MW5101301
• Device Sequence Number: 1
• Product Code: OJH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMPJ05911
• Device Catalogue Number: CMPJ05911
• Device Lot Number: 21CBE188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1