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

Model Number 1029754

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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 bone wax does not adhere to the bone.Reported by a neurosurgeon.Patient consequence: difficulty with haemostasis, on application the wax does not penetrate havers' canals.No plasticity.Date of incident: 6 months ago.Type of operation: lumbar laminectomy, cervical arthrodesis.No further information is received.

Manufacturer Narrative

Analysis and results: there is a previous complaint of this code batch but regarding a labeling issue.We manufactured and distributed in the market (b)(4) units of this code batch.There are no units in stock in b.Braun surgical's warehouse.Without closed samples and/or defective samples a proper analysis cannot be performed.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfils usp/ep and bbs requirement.Final conclusion: without samples 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.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it.Please note that when no samples are received our analysis is very limited.We regret any inconvenience this issue may have caused and thank you for your collaboration.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
• MDR Report Key: 12023576
• MDR Text Key: 261975188
• Report Number: 3003639970-2021-00237
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: K000021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: 219382
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1