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

Model Number 1029754

Device Problems Failure To Adhere Or Bond (1031); Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 4 unopened units (each one of one different batch).Analysis and results: there are no previous complaints of any of the involved code-batches.Manufactured (b)(4) units of the batch 216034, (b)(4) units of the batch 215492, (b)(4) units of the batch 216104 and (b)(4) units of the batch 216102.There are no units in stock of any of the batches.Batch manufacturing records of the involved reference-batches have been checked and no deviations have been found.The following parameters of each sample received and other three different batches have been tested: smell, color, appearance, suppleness and adhesive behavior.All batches are into the current range for this product.No differences have been found between the different batches analyzed: - the smell is the usual one, there is not smell rancid.- the color is white yellow as usual.- the appearance is according to the visual standard.- regarding the suppleness, the products can be kneaded well.- and concerning the adhesive behavior, the product hold well on instruments.Final conclusion: complaint is not justified.Results of the samples received fulfills the oem requirements.Note is taken of this incident 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.

Event Description

Country of complaint: (b)(6).It was reported that there is a problem with the bone wax, the product crumbles upon use.The product does not stick well to the instruments and is not effective.All med watch submissions related to this report are: 2916714-2016-00960, 2916714-2016-00961, 2916714-2016-00962.

• Brand Name: BONE WAX 24X2.5G
• Type of Device: BONE WAX
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6126262
• MDR Text Key: 60868242
• Report Number: 2916714-2016-00961
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K000021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: 216104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Distributor Facility Aware Date: 11/04/2016
• Date Manufacturer Received: 10/24/2016
• 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