MAUDE Adverse Event Report: CONMED CORPORATION STERNUM SAW BLADE GUARD; SAW, PNEUMATICALLY POWERED

Catalog Number 00505900600

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

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 distributor reported on behalf of their customer that the 00505900600, sternum saw blade guard, was being used during a cardiac surgery on (b)(6) 2020 when the device broke.A component of the device fell into the surgical site and was retrieved using forceps.The surgeon sustained a cut on his hand that was repaired using an over the counter (otc) medication (adhesive plaster).There was no report of impact to the patient.Although there was report of injury to the user on the customer complaint form, the steps described through follow up assessment questioning do not equate to the definition of serious injury per cfr title 21, part 803.1w since the medication used can be obtained without a prescription and without a medical professional for application.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

D4 is not a valid lot number; however, what was reported to conmed is being reported.Examination of returned device 00505900600, found blade guard broken off at the weld.Examination was performed per print 22505900600, rev- ab.The manufacturing documents from the device history record could not be reviewed since a valid lot number was not provided.Also, the date of manufacture is left blank due to the lot number reported being invalid.A two-year lot history review could not be performed since a valid lot number was not provided.A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode.During this same time frame 1,305 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 0.002.Per the instructions for use, the user is advised the following: warnings: 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 if, upon receipt, package is opened, damaged, or shows any signs of tampering.Prior to each use, perform the following: ensure all accessories are correctly and completely attached.Perform the required preoperational functional tests for the equipment and accessories.Always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.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: STERNUM SAW BLADE GUARD
• Type of Device: SAW, PNEUMATICALLY POWERED
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 10350361
• MDR Text Key: 202699018
• Report Number: 1017294-2020-00329
• Device Sequence Number: 1
• Product Code: KFK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00505900600
• Device Lot Number: OCT00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/17/2020
• Patient Sequence Number: 1