MAUDE Adverse Event Report: CONMED CORPORATION 9.5 X 25.5 X 0.4MM MICRO SAGITTAL BLADE, FINE, QTY 5; FLAT BLADE

Model Number	5023-138
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported by a conmed country contact on behalf of the facility that the (b)(4)blade was dull during a hallux procedure.The issue repeated with 4 blades of the same lot during the procedure which allegedly caused "damage to the bone".To date additional information regarding the patient status and procedure has not been made available although a request has been made to the user facility.Although no injury to patient or user was reported, this report is being raised as an injury due to the statement from the user of "damage to the bone" caused by a malfunction of the device.
Additional Manufacturer Narrative
The evaluation of the blades returned from the user were found to be new devices.The original, used devices were not returned for evaluation.An examination of the blades was performed and the devices were found to have met specification.No discrepancies with the devices could be located.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A review of this lot number, with (b)(4) pieces manufactured, showed no other complaint for this lot product and failure mode.(b)(4).It is good medical practice to inspect and/or test equipment prior to use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 9.5 X 25.5 X 0.4MM MICRO SAGITTAL BLADE, FINE, QTY 5
• Common Device Name: FLAT BLADE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7363707
• Report Number: 1017294-2018-00047
• Device Sequence Number: 1608184
• Product Code: GFA
• UDI-Device Identifier: 10845854001974
• UDI-Public: (01)10845854001974(17)221102(10)878425
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2022
• Device Model Number: 5023-138
• Device Catalogue Number: 00502313800
• Device Lot Number: 878425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other