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

Model Number 1029754

Device Problem Chemical Problem (2893)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).The bone wax is not staying on the bone during filling.It comes off easily.However it remains on the applicator or on the dabber without issue.

Manufacturer Narrative

Us reporting agent notified on (b)(6) 2015.Manufacturing site evaluation: evaluation on-going at manufacturing site.

• Brand Name: BONE WAX 24X2.5G
• Type of Device: BONE WAX
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 0819 1; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4437398
• MDR Text Key: 5387907
• Report Number: 2916714-2015-00035
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K000021
• 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: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: 214092
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• 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