MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION MEDLINE BONEWAX; BONE WAX WHITE

Model Number	903
Medical Device Problem Code	Thickening of Material (4056)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sterile samples from the reported lot, including the actual devices, were not returned for visual review or analysis.Without the actual reported devices, photos of the devices, or detailed information on the method used to remove the device from the packaging, preoperative preparation of the device, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.Review of labeling 03-5634r4: indications for control of bleeding from bone surfaces during surgical operations.Contraindications: bone wax should not be used where rapid osseous regeneration and fusion are desired.Warnings: do not resterilize or subject bone wax to excessive heat.Bone wax may inhibit osteogenesis and may act as a physical barrier to the reparative process.Do not use if the package is opened or damaged.Discard open, unused bone wax.Precautions bone wax should be used sparingly.Use the minimum amount necessary to achieve hemostasis; and remove as much of the bone wax as possible after hemostasis is achieved.The package should be opened just prior to use to minimize the possibility of contamination and excessive drying.Directions and dosage use bone wax immediately after removal from the package.Using aseptic technique, take 1 to 1.5 grams of bone wax, manipulate with the ngers to soften, and apply to bone surface.Optimum working temperature: 70° - 74° f (21° - 23° c).
Event or Problem Description
It was reported on (b)(6) 2025 that, during surgery, the bonewax did not adhere well and blood was lost.No patient injury was reported.Additional bonewax was applied to stop the bleeding and the procedure was completed.

• Brand Name: MEDLINE BONEWAX
• Common Device Name: BONE WAX WHITE
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b, ejido franciso villa; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood
• Manufacturer Contact: joseph scoma ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 21632622
• Report Number: 3010692967-2025-00012
• Device Sequence Number: 12637179
• Product Code: MTJ
• UDI-Device Identifier: 00848782005611
• UDI-Public: 00848782005611
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 903
• Device Lot Number: CC07AFX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown