MAUDE Adverse Event Report: CONMED CORPORATION GRAFTMAX FLEX XACTPIN GUIDE PIN; BIT, SURGICAL

Catalog Number KS-FGP24

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2019

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 sales representative reported on behalf of the customer that the, ks-fgp24, device "pin broke itself inside the femoral condyle of the patient after 3cm drilling, the fragment was 4 cm and the surgeons were able to remove it from the patient with a kocher instrument" during a acl knee surgery on (b)(6) 2019.There was an ~15-minute delay in the procedure and another like device was used to successfully complete the surgery.There was no report of injury to patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Examination of the returned used device, item ks-fgp24, found the guide pin bent and broken off at the etch line.Broken piece is approximately 2.100 of the inch and was returned for the evaluation.The returned used device shows signs of misuse.However, examination performed per print could not find any issues with guide pin dimensions.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 was found to have met all specifications prior to shipment.This is the only complaint 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 one complaint, regarding one device, 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 0.0002.Per the instructions for use, the user is advised the following: contraindications: insufficient quality or quantity of bone for drilling.Warnings: this device should not be advanced with a mallet; do not expose flex xactpin in dry environment while drilling as the flex xactpin may break; do not bend flex xactpin to a radius smaller than 80mm.Precautions: inspect prior to use and after removal to ensure it is in good physical condition and functions properly.Do not use if product is damaged.Do not bend the flex xactpin prior to insertion.Do not use instruments to pry, as bending or breakage may occur.Use with other instrumentation may result in device failure.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: GRAFTMAX FLEX XACTPIN GUIDE PIN
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 8674046
• MDR Text Key: 147194055
• Report Number: 1017294-2019-00072
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 10845854042762
• UDI-Public: (01)10845854042762(17)231107(10)976112
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2023
• Device Catalogue Number: KS-FGP24
• Device Lot Number: 976112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1