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

Model Number	901
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: 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
• Report Number: 3014527682-2023-00004
• Device Sequence Number: 20642333
• Product Code: MTJ
• UDI-Device Identifier: 00848782008247
• UDI-Public: 00848782008247
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown