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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED LINVATEC HALL 50 OSCILLATING SAW HANDPIECE SAW, POWERED, AND ACCESSORIES

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CONMED LINVATEC HALL 50 OSCILLATING SAW HANDPIECE SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO7300B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
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 handpiece was manufactured on 21-may-2014. A review of the device history record (dhr) for this handpiece showed no discrepancies during manufacturing that could have caused or contributed to this problem. The handpiece was subject to a routine inspection and test by a qualified repair technician at the conmed international affiliate service facility in australia. The device was tested and found the unit performed to 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 pro7300b hall 50 oscillating saw was used in a hip arthroplasty to remove the head of the femur, 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 conmed hall 50 oscillating saw handpiece was in the theater. There has been no complaint report received from the user facility regarding the performance of the handpiece and there is no suggestion that the hall 50 oscillating saw handpiece played any part in the cardiac arrest resulting in the patient's subsequent death.

 
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Brand NameHALL 50 OSCILLATING SAW HANDPIECE
Type of DeviceSAW, 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 Key5114135
MDR Text Key27144637
Report Number1017294-2015-00050
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2015
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPRO7300B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/24/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/21/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 09/30/2015 Patient Sequence Number: 1
Treatment
SMITH&NEPHEW LONG STEM HEMIARTHROPLASTY PROSTHESIS
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