MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. BONE WAX 24X2.5G

Model Number 1029754

Device Problem Biocompatibility (2886)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Lot number is not known.The lot numbers suspected are 219291, 219185 and 219233.If additional information becomes available a follow-up report will be submitted.

Event Description

It was reported an issue with bone wax product.The client reported that patients have experienced infection and nonconsolidation following the use of the bonewax for genioplasty procedures.The hypothesis would be the non-absorbable nature of the product.14 patients concerned and 2 of them had to be re-operated.The doctor will reconvene all patients operated in 2021 and 2020.The bone wax is also used in orthopedics (no information on possible problems).The infection was the indicator that revealed the problem.The problem reported was the non-consolidation of the bone, on which the infection develops, which would be linked to the non-absorbable nature of the product.14 is the number of patients operated by the surgeon in 2021.This report is for patient 3.Additional information has been requested.Mfr report numbers for the 14 patients are: 3003639970-2022-00048 , 3003639970-2022-00049 , 3003639970-2022-00051, 3003639970-2022-00052, 3003639970-2022-00053, 3003639970-2022-00054, 3003639970-2022-00055, 3003639970-2022-00056, 3003639970-2022-00057, 3003639970-2022-00058, 3003639970-2022-00059, 3003639970-2022-00060, 3003639970-2022-00061.

Manufacturer Narrative

Analysis and results: the involved batch is not known.The suspected batches are 219291, 219185 and 219233.There are no previous complaints of the three possible batches related to a similar issue.We have received 14 different cases from the same customer regarding the same issue.We manufactured (b)(4) units of the batch 219291, (b)(4) units of the batch 219185 and 24,000 units of the batch 219233.There are 648 units blocked in our stock of the batch 219185 and no units in stock of the batches 219291 and 219233.The device history record of each batch has been reviewed and no deviations have been found.We have not received any sample from the customer for analysis.We have received 1 box (24 units) from stock of the batch 219185 for analysis.Sterility test has been performed to the samples received from stock of the batch 219185.6 replicates were introduced into bottles with tryptone soya broth (tsb) medium and 4 replicates into bottles with fluid thioglycolate medium (ftm), in sterile conditions.The bottles were incubated for 14 days at 20ºc - 25ºc and at 30ºc - 35ºc, respectively, to verify their sterility.The tested replicates fulfil the sterility test after 14 days of incubation in tsb and ftm mediums, as all bottles remained absent of turbidity (absence of bacterial growth).The analyzed samples from stock of the batch 219185 fulfil the specifications for the sterility test.According to the results of the tests realized to the closed samples received from stock of the suspected batch 219185 and the batch manufacturing records review, the products comply with our specifications; therefore, we do not see any manufacturing fault or material defect that could have caused the incidence.As stated in the contraindications of the instructions for use of the product: bone wax must not be applied to infected regions, as bone wax can promote infections.Do not use bone wax in patients allergic to beeswax.Also, in mode of application is reported that: it is recommended that, using aseptic technique, the bone wax is first kneaded in the hand to soften it and then applied to the bone with a spatula to staunch the bleeding at the bone.On the other hand, in warnings the following is mentioned: care should be taken to use as small quantity as possible, since otherwise regeneration of the bone can be adversely affected.Bone wax remains within the body.Remove excess of bone wax from the operative site.Do not reuse the product: infection hazard for patients and/or users and impairment of the product functionality due to reuse.Risk of injury, illness or death due to contamination and/ or impaired functionality of the product.Bone wax should be used directly after the package is opened.Only use if package is undamaged.And the following is stated in the side effects: bone wax can cause foreign body reaction, inflammation and granuloma.Haematoma and serous accumulation may occur after the use of bone wax.Checking the complaint history record, there are no previous complaints for bone wax product in the last five years regarding infection.Final conclusion: without samples of the batches 219291 and 219233, we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done, and the case is not confirmed due to lack of evidence.On the other hand, although the results of the samples received from stock of the batch 219185 fulfil the b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: BONE WAX 24X2.5G
• Type of Device: BONE WAX
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 13533060
• MDR Text Key: 285607947
• Report Number: 3003639970-2022-00050
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K000021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other