MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. BONE WAX STICK

Model Number 1029755

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Fistula (1862); Inflammation (1932)

Event Date 04/05/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Surgery in (b)(6) 2012 for an exostosis of the scapula.Using bone wax for hemostasis.Inflammatory phenomenon/allergic collection and fistula at the level of the skin that required several surgical revisions in (b)(6) 2012.During these revisions, several pieces of wax were noticed.In (b)(6) 2014, an mri showed an anterior and retro shoulder's collection.Fistulisation of a collection at the level of the skin, non-infectious inflammation noted, which required re-operation.Two fragments suspected to be wax, size 1 mm, were found, with inflammatory response.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Reported device not marketed in the us; however, similar devices and/or production procedures are used on us registered products.Manufacturing site evaluation: samples received: no sample available.No information of the exact batch number, several batches possible.Analysis and results: in the clinical evaluation report of the product it is also informed in the risk analysis paragraph: a comprehensive risk analysis has been conducted for the product "bone wax" (s.Attachment of the cer).Most of the risks that occur using the product are well known for a very long time and well manageable.Risks that can arise from the application of the product are - among others - tissue incompatibilities.These are referred to in the instructions for use.This risk is potentially relevant, but does not threaten/endanger life and limb of the patient.As is evident from the literature evaluation, a particularly generous application of bone wax may lead to granulomas etc.But in mose cases these disappear completely after removing the residual bone wax in contraindicated tissues and body areas represents a risk for the patient, as for example the use in brain tissue leads to adverse reactions in sensitivity body areas.Review manufacturing documentation: there is a list from in this period supplied batches to (b)(6).The manufacturing documentation (dhr) was checked.There was no deviation in the process.In the instruction for use it is pointed out the side effects that may occur hematoma and serious accumulations after the use of bone wax.It is also recommended to keep the amount to be applied to a minimum.Also mentioned in the clinical evaluation of bone wax: "as is apparent from the literature evaluation review, it comes particularly by generous application of bone wax to granulomas, but they disappear completely in most cases, by removing the residual wax".No corrective action required.Complaint will be maintained for trending.

• Brand Name: BONE WAX STICK
• Type of Device: BONE WAX
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4058164
• MDR Text Key: 18867453
• Report Number: 3005673311-2014-00057
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1029755
• Device Catalogue Number: 1029755
• Date Manufacturer Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 7 YR