MAUDE Adverse Event Report: CONMED CORPORATION 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	5071-181
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
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
The customer reported that the (b)(4), 19.5 x 86 x 1.27mm (.050 inch) oscillator blade, qty 5, broke during a total knee arthroplasty procedure on (b)(6) 2018.This occurred while the surgeon was cutting the femur with a guide.The breakage was removed from the surgical site causing a slight delay in the procedure.It is reported that there was not any surgical intervention required for this incident and neither the patient nor the user sustained any injury caused by the breakage.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The evaluation of the returned, used device found the blade has one broken tooth and one bent tooth.The broken tooth was not returned.The blade has damage on both sides of the blade surface.The examination was performed per specification.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.A lot history review found there are two complaints for this lot number and failure mode within the past two years.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 149,319 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 0.00001.Per the instructions for use, the user is advised the following: warnings: do not use the equipment if, upon receipt, the package is opened, damaged, or shows any signs of tampering precautions: refer to the appropriate conmed linvatec handpiece instruction manual for device specific warnings.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 19.5 X 86 X 1.27MM (.050 INCH) OSCILLATOR BLADE
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7502107
• Report Number: 1017294-2018-00059
• Device Sequence Number: 16179972
• Product Code: GFA
• UDI-Device Identifier: 10845854009086
• UDI-Public: (01)10845854009086(17)230319(10)916757
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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
• Operator of Device: Physician
• Device Expiration Date: 03/19/2023
• Device Model Number: 5071-181
• Device Catalogue Number: 00507118100
• Device Lot Number: 916757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 05/29/2018
• Patient Sequence Number: 1