MAUDE Adverse Event Report: CONMED CORP. CONMED SAW/POWER TOOL; SAW, POWERED, AND ACCESSORIES

Device Problems Vibration (1674); Unintended Movement (3026)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2014

Event Type  malfunction  

Event Description

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.He did not qualify what normal was other than to say usually the screw felt tighter/more resistant when adjusted in previous cases.The surgeon wanted to check if it was possible that the threads on the screw could slightly wear from repeated use thus causing the screw to vibrate more than through the tapped bore of the cutting block and changing the resection height, as opposed to a newer block that may feel more sticky or have more friction through its range of adjustment and be less prone to vibrate loose and change the resection height.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CONMED SAW/POWER TOOL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED CORP.
• MDR Report Key: 17537567
• MDR Text Key: 321521339
• Report Number: MW5144440
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1