MAUDE Adverse Event Report: B.BRAUN SURGICAL SA BONE WAX 24X2.5G

Model Number 1029754

Device Problems Failure To Adhere Or Bond (1031); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).According to the customer this bone wax is very sticky and does not remain stuck where it is placed.

Manufacturer Narrative

Samples received: 1 unopened unit.Analysis and results: there are no previous complaints of the same reference-batch.We manufactured and distributed in the market 1,488 units of this code-batch.There are no units in our stock.We have received one closed sample to analyze this complaint.We have checked this sample and is the current and usual one.We have not found differences to the standard product.The batch manufacturing record has been reviewed and no deviations have been found.Final conclusion: although the results of the sample received fulfil the product specifications, we take note of this incidence in order to assess if new or additional actions are needed.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 SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7591493
• MDR Text Key: 110851635
• Report Number: 3003639970-2018-00371
• 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: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: 217332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Distributor Facility Aware Date: 06/01/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other