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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED LARGO SAW; SAW, POWERED, AND ACCESSORIES
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CONMED LARGO SAW; SAW, POWERED, AND ACCESSORIES Back to Search Results
Lot Number UNKNOWN
Device Problems Vibration (1674); Unintended Movement (3026)
Patient Problem Bone Fracture(s) (1870)
Event Date 06/17/2014
Event Type  Injury  
Event Description
This complaint was created due to the receipt of a medwatch report mw5144440 on 02oct23.The report was found to be written against unknown saw, that was being used during an unknown procedure on (b)(6) 2014.The report stated, ¿the surgeon used a buehler block to cut the distal femur resection.During saw operation, the saw was noted to vibrate excessively/more than normal, which caused the buehler adjustable cutting slot section to move, changing the resection level during the cutting action.Pins were not inserted in cut slot section ( distal section as seen when orientated on femur).Three pins were inserted in proximal base section of block.The surgeon rectified this by repositioning cutting block and inserting extra pins before re-performing the femoral distal resection.The surgeon has requested testing of the block in question as it was noted that the resection adjustment screw was possibly looser than normal.Per (b)(4), he does not believe the block was damaged by the saw and the surgeon does not suspect this either.The surgeon believes the saw had a mechanical issue that caused it to vibrate more than normal and that this excessive vibration caused the adjustment screw in the block to vibrate more than normal which resulted in the adjustable cutting slot moving from its set position.The number of pins used and where they were located to secure block may also be a factor.The surgeon rectified the situation immediately and then inspected the block at end of operation.He believes the adjustment screw felt as though it was looser/less resistant than normal as he tested the ability to change resection height with the screw driver while holding the block.¿.No further information is available since the reporter has elected to stay anonymous.This report is being raised on the reported injury due to a patient having more bone resected than intended.
 
Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
 
Event Description
This complaint was created due to the receipt of a medwatch report mw5144440 on 02oct23.The report was found to be written against unknown saw, that was being used during an unknown procedure on (b)(6) 2014.The report stated, ¿the surgeon used a buehler block to cut the distal femur resection.During saw operation, the saw was noted to vibrate excessively/more than normal, which caused the buehler adjustable cutting slot section to move, changing the resection level during the cutting action.Pins were not inserted in cut slot section ( distal section as seen when orientated on femur).Three pins were inserted in proximal base section of block.The surgeon rectified this by repositioning cutting block and inserting extra pins before re-performing the femoral distal resection.The surgeon has requested testing of the block in question as it was noted that the resection adjustment screw was possibly looser than normal.Per (b)(4), he does not believe the block was damaged by the saw and the surgeon does not suspect this either.The surgeon believes the saw had a mechanical issue that caused it to vibrate more than normal and that this excessive vibration caused the adjustment screw in the block to vibrate more than normal which resulted in the adjustable cutting slot moving from its set position.The number of pins used and where they were located to secure block may also be a factor.The surgeon rectified the situation immediately and then inspected the block at end of operation.He believes the adjustment screw felt as though it was looser/less resistant than normal as he tested the ability to change resection height with the screw driver while holding the block.¿.No further information is available since the reporter has elected to stay anonymous.This report is being raised on the reported injury due to a patient having more bone resected than intended.
 
Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The service history review cannot be conducted as a serial number was not provided.A device history record review cannot be conducted as a serial number was not provided.A two-year review of complaint history revealed there has been a total of 6 complaints, regarding 6 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised that it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories.Do not use equipment other than intended use.We will continue to monitor for trends through the complaint system to assure patient safety.
 
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Brand Name
SAW
Type of Device
SAW, 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
samantha dewberry
525 french road
utica, NY 13502
3152230184
MDR Report Key17996146
MDR Text Key326387261
Report Number1017294-2023-00098
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Patient Sequence Number1
Patient EthnicityNon Hispanic
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