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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION MICROFREE RECIPROCATING SAW SAW, POWERED, AND ACCESSORIES

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CONMED CORPORATION MICROFREE RECIPROCATING SAW SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number PRO8400SB
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2020
Event Type  Malfunction  
Manufacturer Narrative

At time of filing, although expected, the reported device has not been 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

On behalf of the customer, the conmed representative reported issues involving the pro8400sb, microfree reciprocating saw sn# (b)(4) that occurred at (b)(6), on (b)(6) 2020. Information received was the saw blade kept falling out of the collet while in use in a patient. Clarification was received that indicates during a left total ankle replacement the reciprocating saw blade fell out of the collet on the saw twice. Prior to using the saw, the blade was appropriately seated and placed in collet. The collet was hand tightened. The blade fell out following approximately 5 seconds of use on patient. The surgeon removed the blade from the patient's ankle and reattached the blade to the handpiece. After the blade fell out the second time, the blade was removed by hand, fully intact, and the handpiece was set aside. The surgeon completed the necessary cut using a large bone sagittal saw and the procedure was successfully completed with no further issue. There was no impact or injury to the patient. This report is being raised on the basis of malfunction with potential for injury upon reoccurrence as the blade fell into the patient but was removed.

 
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Brand NameMICROFREE RECIPROCATING SAW
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
CONMED CORPORATION
11311 concept blvd
largo, fl
Manufacturer (Section G)
CONMED CORPORATION
11311 concept blvd
largo FL 33773 4908
Manufacturer Contact
tracey weiselbenton
11311 concept blvd
largo, FL 33773-4908
7273995557
MDR Report Key10411053
MDR Text Key205688593
Report Number1017294-2020-00354
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2020
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPRO8400SB
Device LOT Number20190492
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/27/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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