MAUDE Adverse Event Report: CONMED CORPORATION MCLASS OSCILLATING SAW BLADE

Catalog Number T250-127-90

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/07/2018

Event Type  Injury  

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 conmed representative reported that a patient had to undergo a second surgery on (b)(6) 2018, to remove a piece of saw blade that was left in the knee during a total knee replacement surgery on (b)(6) 2018.Additional information was received along with photographs showing the metal fragments that were retrieved.There were 2 pieces of the metal noted on x-ray.The pieces were completely removed.The complaint form does not have a catalog nor a lot number listed, but the customer alleges it was a conmed product.At this time, the catalog number, lot number and type of metal fragment are still unknown.The fragment is being returned for evaluation, but at this time it is not confirmed to be a conmed product.This report is being raised on the basis of patient injury.

Manufacturer Narrative

Correction: d1 previously stated stryker oscillating saw blade.D2 catalog number previously stated stk190-089-90.Evaluation: the customer returned for evaluation only the broken piece.Blade was not returned.Visual examination of the returned broken piece, item t250-127-90 found the blade was broken at the hub.This is a technique dependent device and the most likely cause of this suspected failure is user related.Suspect, excessive force, lateral side loading and/or stalling of the device, was used that caused the blade to break off.The manufacturing documents from the device history record could not be reviewed as no lot number was provided.The manufacture date could not be established due to the unknown lot number.(b)(4).Per the instructions for use, the user is advised the following; do not use the saw blade to pry, remove bone grafts, or as a leverage point.Patient or user injury could occur.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MCLASS OSCILLATING SAW BLADE
• Type of Device: SAW BLADE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 8223809
• MDR Text Key: 132375501
• Report Number: 1017294-2018-00196
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: T250-127-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 73 YR