MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE STERILE SKIN MARKER REGULAR TIP 100CT; MARKER, SKIN

Catalog Number DYNJSM02

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

Event Type  malfunction  

Event Description

Custom packs in total knees and hips have 4 to 6 medline skin markers that come apart unexpectedly when touched or handled.After handling these markers to mark the skin or bone pre-op and intra-op they fell apart into the surgeons hands into three parts.Unable to give a specific lot number.The pens come in a variety of surgical packs.

• Brand Name: MEDLINE STERILE SKIN MARKER REGULAR TIP 100CT
• Type of Device: MARKER, SKIN
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 12459446
• MDR Text Key: 271038150
• Report Number: 12459446
• Device Sequence Number: 1
• Product Code: FZZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/01/2021,04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNJSM02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2021
• Date Report to Manufacturer: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1