MAUDE Adverse Event Report: SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V. BONE WAX WHITE; WAX,BONE

Model Number 903

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

Surgical specialties bone wax white (ref 903; lot #c318two; exp 02/17/2027).This bone wax was completely dry and brittle when opened onto the sterile field.We opened four more packages of the same lot #.All packages were dry and brittle.We ended up having to open a new box with a different lot # to get a good pliable wax.

• Brand Name: BONE WAX WHITE
• Type of Device: WAX,BONE
• Manufacturer (Section D): SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V.; 247 station drive, ne1; westwood MA 02090
• MDR Report Key: 16416418
• MDR Text Key: 309957165
• Report Number: 16416418
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 903
• Device Catalogue Number: SS903
• Device Lot Number: C318TWO
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1