MAUDE Adverse Event Report: ETHICON INC. BONE WAX 12 X 2.5GRAMS; WAX, BONE

Catalog Number	W31G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a neurosurgery on (b)(6) 2025 and bone wax was used.During the procedure, the mastoid cells were plugged with bone wax.The surgeon reported that the bone wax did not forge or settle, nor would it adhere correctly in the mastoid cells.It remained in paste and was not like a uniform mass that one could distribute in the bone.The patient underwent re-intervention because that bone wax probably peeled off and did not stick to the bone.The surgeon opined this was a totally preventable complication, simply with the sealing of the cells, which was one.The surgeon commented that because of the poor quality of the bone wax, it probably peeled off and made the fistula.The surgeon stated that they put the wax, sealant and everything possible to prevent a fistula.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H6 component code: g07002 device not returned attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A photo upon which this medwatch is based has been received, however, the photo evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information: a2, a3a, a4, b7, d4 expiration date, d4 udi number, e1, h3, h4, h6.Additional information was requested, and the following was obtained: age: 52, sex: female, weight: 84, bmi: 34.5.Name of the procedure? on (b)(6) 2025 neurovascular decompression of facial nerve, by suboccipital craneotomy.On (b)(6) 2025 correccion fistula csf in posterior skull base, suboccipital route.What type of neurosurgery? programmed.Diagnosis and indication of the initial surgical procedure? facial nerve disorder, unspecified.What was the condition of mastoid cells (normal, thin, calcified, fragile, diseased)? bone wax positioned in previous surgery for the closure of migrated and displaced mastoid cells is evidenced.Was the poor quality of bone wax noticed during the initial or postoperative procedure? initial (difficult to manipulate) posterior (bone wax displaced from the mastoid, with csf fistula contained).How many days after the operation did the fistula occur? (b)(6) 2025.What symptoms did the patient experience after the index surgical procedure? start date? (b)(6) 2025 patient pop surgical treatment hemifacial spasm at stable time, now with left nostril csf fistula, paradoxical fistula is considered describe the re-intervention required for this event, including dates and results.On (b)(6) 2025 under general anesthesia, in supine position with protection of pressure zones, head of 3 pins.Asepsis and antisepsis of the skull, surgical area is covered with sterile fields scalp infiltrated with bupivacaine with epinefine 10 cc incision by previous left retrosigmoid wound dissection by planes to the skull, bone wax positioned in previous surgery for the closure of mastoid cells migrated and displaced.Primary duroplasty is performed again with nurolon 4-0, multiple valsal maneuvers are performed without evidencing csf output is positioned epidural beriplast 3.Again bone wax in cells mastoid closing by planes with pds 0, 2-0, ethylon 3-0 no complications.Other relevant patient background / concomitant medications? pathological: right haemofacial spasm for 6 years in treatment with botulinum toxin, last application in (b)(6) 2025.- pharmacological: denies.What is the opinion of the doctor regarding the etiology or the factors that contribute to this event? on friday, (b)(6) 2025, the patient was taken to a posterior fossa surgery, to perform a microvascular decompression of the facial nerve, during the surgery in the process of sealing the mastoid cells with bone wax (standard procedure in this surgery), poor quality of bone wax is evident, not allowing adherence and proper sealing of them, as is usual in this procedure.Therefore, a hermetic closure of the duramadre was performed and fibrin sealant (beriplast) was positioned to decrease the risk of fistula, however presented in the postoperative paradoxical csf fistula, which requires new intervention, for exploration and sealing of the mastoid cells again, the above in relation to the poor quality of the bone wax used.What is the current state of the patient? during the postoperative period of the second intervention, the occurrence of impossibility for bilateral ocular opening due to decreased strength in the eyelids and tongue, which have been progressively improved, without evidence of fatigue at physical examination.Currently, without palpebral ptosis, without dysphagia or dysphonia.Control study with single-fiber emg will be carried out in 6 months.It is registered on (b)(6) 2025.Control in 3 months by neurology.Name of the surgeon? dr.(b)(6).Regarding availability: the customer indicates that it is not currently available.Additional h6 investigation findings: c22 - photo review.Additional h3 investigation summary: this is an analysis for a photo and audio submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos shows a sales unit box with w31g product codes, the lot #aw3637, expiration date 2025- 02 packaging information.A media audio was received with the description of the event.Based on the photo and audio review, the event reported is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the device was not returned our evaluation is limited.We value the opportunity to fully analyze the device upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: BONE WAX 12 X 2.5GRAMS
• Common Device Name: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22742830
• Report Number: 2210968-2025-09179
• Device Sequence Number: 7534028
• Product Code: MTJ
• UDI-Device Identifier: 10705031056992
• UDI-Public: (01)10705031056992(17)300131(10)AW3637
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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 Catalogue Number: W31G
• Device Lot Number: AW3637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 84 KG