MAUDE Adverse Event Report: CONMED LINVATEC HALL 50 2-TRIGGER MODULAR HANDPIECE; SAW, POWERED, AND ACCESSORIES

Catalog Number PRO7200B

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 09/11/2015

Event Type  Death  

Manufacturer Narrative

It is understood the patient was undergoing a hip arthroplasty as a result of secondary (metastatic) breast cancer.It is suggested that the patient may have suffered "bone cement implantation syndrome" since the cardiac arrest occurred approximately 12 minutes following the use of a large quantity of bone cement being used to cement the femoral prosthesis.Alternatively, the patient may have suffered a fat embolism.The pro7200b handpiece was manufactured on 18-mar-2014 and the pro1547 attachment was manufactured on 31-mar-2014.A review of the device history records (dhr's) for these devices showed no discrepancies during manufacturing that could have caused or contributed to this reported problem of "cardiac arrest".The handpieces and attachment were all subject to a routine inspection and test by a qualified repair technician at the conmed international affiliate service facility in australia.Each device was tested and found met manufacturer specifications and passed all functional test requirements with no problems noted.A review of the device complaint history shows there have been no similar events.No further action is planned at this time.

Event Description

It was reported that "during a trial, where a pro7200b hall 50 2-trigger modular handpiece and a pro1547 hall drill/ream attachment were used in a hip arthroplasty for reaming the femoral medullary canal, the patient went into cardiac arrest".This event occurred twelve (12) minutes after a large quantity of bone cement was used to cement the femoral prosthesis".It was subsequently discovered that the patient was deceased despite the attempt by the facility trauma/resuscitation team to revive the patient.Neither the femoral prosthesis nor the bone cement was manufactured and/or supplied by conmed.This report is submitted due to the fact that the patient suffered a cardiac arrest while undergoing a surgical procedure and during which time the handpiece and attachment were in the operating room.There has been no complaint report received from the user facility regarding the performance of the handpiece or the attachment.Additionally, there is no suggestion that the handpiece or attachment played any part in the cardiac arrest resulting in the patient's subsequent death.

• Brand Name: HALL 50 2-TRIGGER MODULAR HANDPIECE
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5113425
• MDR Text Key: 27098213
• Report Number: 1017294-2015-00046
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRO7200B
• Device Lot Number: 2014-0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: (B)(4) LONG STEM HEMIARTHROPLASTY PROSTHESI
• Patient Outcome(s): Death