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

Model Number 1029754

Device Problem Fungus in Device Environment (2316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2021

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 is moldy.The defect was found prior to use, there is no patient involvement.

Manufacturer Narrative

The box has been checked carefully and the results received are the following: analysis and results: there are no previous complaints of this code-batch.We manufactured (b)(4)units ((b)(4)boxes) of this code-batch, and all has been distributed between january-june 2021 to usa.There are no units in stock in b.Braun surgical's warehouse.The device history record (dhr) has been reviewed and no deviations have been found.We have received a closed box that has mold under cellophane as can be seen in enclosed picture.The box has been checked and the carton is wet.The cellophane wrapping was complete and undamaged and unopened.After opening the box, none of the 24 units inside showed any sign of melting.Therefore, the signs on the box that it had been wet are not caused by bone wax product.On the other hand, during opening the carton box, it tore in the area where it had been wet.The conclusions of the investigations are the following: - the wetting of the box must had happened after production, because a wet or previously being wet box would have been broken during the handling in the wrapping machine.- due to the extent of damage, it must have been more than a few drops of water.It looks as if the affected box had been staying in water for a certain time at least several minutes so that the water had enough time break through the folds in the wrapping.- as we are only aware of one single affected box out of the whole batch, we assume that the wetting incident happened after distribution.This means the incident did not take place in manufacturing process because in this case more boxes would have been affected.Taking into account that no other customer complaints for this code-batch have been received concerning a similar issue, we consider an isolated and accidental box.Final conclusion: taking into account that the box received does not fulfil the b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in the box received.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.

Manufacturer Narrative

D4: lot number is added.Analysis and results: there are no previous complaints of this code-batch.We manufactured (b)(4) units ((b)(4) boxes) of this code-batch, and all has been distributed between january-june 2021 to usa.There are no units in stock in b.Braun surgical's warehouse.The device history record (dhr) has been reviewed and no deviations have been found.We have received a closed box that has mold under cellophane.Probably this defect observed was caused by the exposure to a higher temperature and/or humidity environment during transport or storage.In the instructions for use (ifu) and box label of the product is stated that bone wax should be stored at 20 ± 5 °c.Taking into account that no other customer complaints for this code-batch have been received concerning a similar issue, we consider an isolated and accidental box.Final conclusion: taking into account that the box received does not fulfil the b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the failure in the box received.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.U.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.U.; 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: 12554099
• MDR Text Key: 274026241
• Report Number: 3003639970-2021-00492
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 220182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 09/30/2021
• Supplement Dates Manufacturer Received: 01/19/2022; 01/26/2022
• Supplement Dates FDA Received: 01/20/2022; 01/27/2022
• 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