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 Consequences Or Impact To Patient (2199)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been received into conmed's complaint system 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 an issue with the ks-fgp24, graftmax flex xactpin guide pin, lot 976114 that occurred during an acl reconstruction on (b)(6) 2020 in (b)(6).It was reported that the pin broke when drilling in femoral condyle.It was broken just at the end of its thinner part.The broken part was removed from the patient.A rigid c8677s was used to finish the surgery.It is indicated that there was no impact or injury to the patient and the procedure was successfully completed with a 15- minute delay by using a c8677s.Additional information was received indicates it was the first time the device was used as it was opened for that surgery.It broke during first drilling attempt.The graftmax curved drill guide and the power tool attached to the flex guide pin were being used when the device broke.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The customer's reported complaint of the pin breaking when drilling in femoral condyle was confirmed.The returned used device, item ks-fgp24, was evaluated and confirms the reported problem of breakage.The returned device failed function tests; due to broken machined drill tip, however, condition of the device also shows signs of misuse, guide pin is bent in the middle of the shaft, due to excessive force.The broken drill tip was not returned for the evaluation.It is suspected that hard bone was drilled during the tunnel depth.Examination performed per print could not find any issues with critical 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 were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A lot history review was conducted and found this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 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 0.0007.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu the user is also advised to not bend flex xactpin to a radius smaller than 80mm.Do not bend the flex xactpin prior to insertion.Do not use instrument to pry, as bending or breakage may occur.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 4908
• MDR Report Key: 9641909
• MDR Text Key: 217417086
• Report Number: 1017294-2020-00022
• Device Sequence Number: 1
• Product Code: GFG
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2023
• Device Catalogue Number: KS-FGP24
• Device Lot Number: 976114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1