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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION HALL50 OSCILLATING SAW BATTERY HPC SAW, POWERED, AND ACCESSORIES

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CONMED CORPORATION HALL50 OSCILLATING SAW BATTERY HPC SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO7300B
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Laceration(s) (1946)
Event Date 02/05/2021
Event Type  Injury  
Manufacturer Narrative
User's age is approximate age, in their (b)(6) as per reporter. 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 customer reported that the device, pro7300b, was being used during right total knee replacement with mako on approximately (b)(6) 2021 when it was reported that the "blade came out during use. Injury to end user - dr. Assistant. No injury to patient. " further assessment questioning found that the handpiece was being used to cut the patella and, on the 3rd, pass the blade dislodged from the handpiece and cut the assistant's hand. The assistant was assessed and returned to work later that day. There was no report of injury, medical intervention or hospitalization for the patient. And there was no report of medical intervention or hospitalization for the assistant. The procedure was completed with a 15-20-minute delay. The blade, 00507114200, will be listed as the concomitant device due to the reporter filing this report against the handpiece and we have no information to support that the blade malfunctioned in any way. This report is being raised on the basis of injury due to assistant's hand being cut.
 
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Brand NameHALL50 OSCILLATING SAW BATTERY HPC
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED CORPORATION
11311 concept blvd.
largo FL 33773
Manufacturer (Section G)
CONMED CORPORATION
11311 concept blvd.
largo FL 33773
Manufacturer Contact
john berga
11311 concept blvd.
largo, FL 33773
7273995358
MDR Report Key11371920
MDR Text Key242513197
Report Number1017294-2021-00074
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPRO7300B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/24/2021 Patient Sequence Number: 1
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