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U.S. Department of Health and Human Services

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

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CONMED CORPORATION STERNUM SAW BLADE GUARD SAW, PNEUMATICALLY POWERED Back to Search Results
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.
 
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Brand NameSTERNUM SAW BLADE GUARD
Type of DeviceSAW, PNEUMATICALLY POWERED
Manufacturer (Section D)
CONMED CORPORATION
11311 concept blvd.
largo FL 33773
Manufacturer (Section G)
CONMED CORPORATION
11311 concept blvd.
largo FL 33773
Manufacturer Contact
john berga
11311 concept blvd.
largo, FL 33773
7273995358
MDR Report Key10350361
MDR Text Key202699018
Report Number1017294-2020-00329
Device Sequence Number1
Product Code KFK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00505900600
Device Lot NumberOCT00
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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