MAUDE Adverse Event Report: CONMED CORPORATION 4.2MM X 13CM 15 DEGREE PRE-BENT LANZA; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 9391M

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation of the reported complaint of breakage is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified, root cause could not be identified.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 and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history for this device family and failure mode, revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame (b)(4) 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 0.0006.Conmed encourages the inspection and/or test of all medical equipment prior to use to ensure all devices are functioning as expected.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 an issue with an 9391m, 4.2mm x 13cm 15 degree lanza, lot # 1036186 that occurred at (b)(6) on (b)(6) 2020.It was reported that the tip broke in the patient.They noted that no bone was hit when the tip broke.The surgeon was able to retrieve the broken piece and finish the case.No other blades were opened to finish the case.Additional information obtained indicated that there was no impact or injury to the patient and the knee arthroscopy procedure was successfully completed using a curved great white 4.2 blade the surgeon was previously using.The device in question had been used for several minutes when it was discovered the fragment in the knee.There was a delay while trying to retrieve shaver fragment, but the exact length of time is unknown.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence (fragmentation falling in the patient).

Manufacturer Narrative

Additional information was received from the reporter on 07february2020 by means of an image of the device in question.The customer's reported claim of "tip broke in the patient" is now confirmed.The device is still not available for return or evaluation, however the provided photographic evidence exhibits the reported event.Please note that the missing piece of the tip is not shown in the photograph.The information in h6 was updated as well as the narrative pertaining to the investigation, however the other information previously submitted remains unchanged and correct at this time.

• Brand Name: 4.2MM X 13CM 15 DEGREE PRE-BENT LANZA
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 9649318
• MDR Text Key: 217417879
• Report Number: 1017294-2020-00034
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 10845854850404
• UDI-Public: (01)10845854850404(17)210107(10)1036186
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2021
• Device Model Number: 9391M
• Device Catalogue Number: 9391M
• Device Lot Number: 1036186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1