Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION HALL50 STERNUM SAW BATTERY HPC; SAW, POWERED, AND ACCESSORIES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONMED CORPORATION HALL50 STERNUM SAW BATTERY HPC; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO7450B
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
The distributor reported on behalf of their customer that the pro7450b device was being used during a sternotomy procedure on (b)(6) 2021 when it was reported the "blade guard fell off while using the saw".Further assessment questions were asked, and it was discovered that the device fell into the patient.Follow up questioning was sent to the distributor to clarify and gather more information about the patient; however, the distributor is still waiting for answers from the facility.No response has been received to date.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
Manufacturer Narrative
An evaluation of the returned device found no fault.The unit function tested and meets all specifications.The guard popping off could not be duplicated.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed and no data was found.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 4 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised to prior to each use, perform the following: ensure all accessories are correctly and completely attached and perform the required preoperative functional tests for the equipment and accessories.Do not contact the moving parts on the handpiece.Injury to the operator may occur.This issue will continue to be monitored through the complaint system to assure patient safety.
 
Event Description
The distributor reported on behalf of their customer that the pro7450b device was being used during a sternotomy procedure on (b)(6) 2021 when it was reported the "blade guard fell off while using the saw".Further assessment questions were asked, and it was discovered that the device fell into the patient.Follow up questioning was sent to the distributor to clarify and gather more information about the patient; however, the distributor is still waiting for answers from the facility.No response has been received to date.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.Update: on 26feb21, after filing the initial report, the following assessment information was received.A component detached from the device, it did not break.The component was retrieved from the patient by hand and the device has been tested prior to use.Patient 60 yrs old, female and bmi normal.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HALL50 STERNUM SAW BATTERY HPC
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED CORPORATION
11311 concept blvd.
largo FL 33773
MDR Report Key11347754
MDR Text Key232557940
Report Number1017294-2021-00076
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPRO7450B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Initial Date Manufacturer Received 02/01/2021
Initial Date FDA Received02/19/2021
Supplement Dates Manufacturer Received03/05/2021
Supplement Dates FDA Received03/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age60 YR
-
-