MAUDE Adverse Event Report: SURGICAL SPECIALTIES SURGICAL SPECIALTIES; BONE WAX

Model Number 901

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/27/2023

Event Type  malfunction  

Event Description

Customer reported: it was brought to my attention in the lami packs that the bone wax is contaminated with what looks like fiberglass.

• Brand Name: SURGICAL SPECIALTIES
• Type of Device: BONE WAX
• Manufacturer (Section D): SURGICAL SPECIALTIES; 1100 berkshire blvd, suite 300; wyomissing PA 19610
• Manufacturer (Section G): SURGICAL SPECIALTIES; 1100 berkshire blvd, suite 300; wyomissing PA 19610
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 16657676
• MDR Text Key: 312704249
• Report Number: 3014527682-2023-00004
• Device Sequence Number: 1
• Product Code: MTJ
• UDI-Device Identifier: 00848782008247
• UDI-Public: 00848782008247
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 901
• Device Catalogue Number: 901
• Device Lot Number: CB04QAO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1