MAUDE Adverse Event Report: AAPBIOMATERIALS GMBH & CO. KG SIMPLEX HV WITH GENTAMICIN US 1 PACK

Catalog Number 6195-1-001

Device Problems Fire (1245); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

The user used electrosurgical pencil to scrape cement; accidentally hit the cauterize button, which ignited the cement.The instructions for use simplex hv gentamicin indicates that methyl methacrylate is a volatile, flammable liquid.

Event Description

Patient having total knee procedure.Implantable hardware being put in using cement.The anesthesiologist noted fire on the floor beside of the pa.A piece of cement was on fire with visible flames.The circulating nurse got a bottle of water and poured over the patient drapes and on the floor.It was then realized that the pa's surgical gown had a large hole in front of her surgical gown.Patient drapes had large holes burned and multiple small holes.Patient was checked for injuries, none observed.The pa was using the electrosurgical pencil to scrape the cement; accidentally hit the cauterize button, which ignited the cement, which then fell onto the drapes and went unnoticed.O.R unit director and charge nurse were immediately notified.At ending surgeon was scrubbed at the time of incident and aware of the situation.Patient was uninjured and went to pacu.No staff injuries occurred.This event underwent a root cause analysis meeting about two weeks after event.During rca meeting, the ortho attending surgeon and pa discussed that the bone cement had a much stronger odor on this data.The surgeon has not been impressed with the overall quality of the bone cement product for the past two years.

• Brand Name: SIMPLEX HV WITH GENTAMICIN US 1 PACK
• Type of Device: NA
• Manufacturer (Section D): AAPBIOMATERIALS GMBH & CO. KG; dieburg ; GM
• Manufacturer (Section G): AAP BIOMATERIALS GMBH & CO. KG; lagerstrasse 11-15; dieburg ; GM
• Manufacturer Contact: lydia heimann ; lagerstrasse 11-15; dieburg ; GM ; 071929107
• MDR Report Key: 5094839
• MDR Text Key: 26550347
• Report Number: 9615014-2015-00006
• Device Sequence Number: 0
• Product Code: MBB
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K12308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Device Operator: Health Professional
• Device Catalogue Number: 6195-1-001
• Device Lot Number: 448BA962JV
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1