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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED LARGO HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE SAW, POWERED, AND ACCESSORIES

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CONMED LARGO HALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO9350B
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Event Description
The sales representative reported on behalf of the customer that the pro9350b, hall titan primecut+ oscillating saw battery hp, was used during an acl reconstruction on (b)(6) 2021 when it was reported, ¿during acl (knee) the new pro9350b lost the terminal part. ¿ there was no report of injury, medical intervention, or hospitalization for the patient. Further assessment questioning found that a component of the device had fallen into the patient and was retrieved by hand. The procedure was completed as planned. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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.
 
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 sales representative reported on behalf of the customer that the pro9350b, hall titan primecut+ oscillating saw battery hp, was used during an acl reconstruction on (b)(6) 2021 when it was reported, ¿during acl (knee) the new pro9350b lost the terminal part. ¿ there was no report of injury, medical intervention, or hospitalization for the patient. Further assessment questioning found that a component of the device had fallen into the patient and was retrieved by hand. The procedure was completed as planned. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
 
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Brand NameHALL TITAN PRIMECUT+ OSCILLATING SAW BATTERY HANDPIECE
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer (Section G)
CONMED LARGO
11311 concept blvd
largo FL 33773
Manufacturer Contact
john berga
11311 concept blvd
largo, FL 33773
7273995358
MDR Report Key12890524
MDR Text Key285169521
Report Number1017294-2021-00363
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPRO9350B
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2021
Is the Device Single Use? No

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