MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP. SIMPLEX; BONE CEMENT

Catalog Number 6197-9-001

Device Problem Unsealed Device Packaging (1444)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2021

Event Type  malfunction  

Event Description

One of the technician¿s went to open a box of cement prior to a case.Upon opening the box, she noted that there wasn't a complete seal on the package of the bone cement monomer.

• Brand Name: SIMPLEX
• Type of Device: BONE CEMENT
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP.; 325 corporate dr; mahwah NJ 07430
• MDR Report Key: 12473964
• MDR Text Key: 271492410
• Report Number: 12473964
• Device Sequence Number: 1
• Product Code: LOD
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6197-9-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1