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

Catalog Number KS-FGP24

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

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 device, ks-fgp24, was being used on (b)(6) 2021 during a cross ligament procedure and ¿during the perforation of the femoral tunnel, the malleable wire broke inside the bone.¿ the doctor was able to retrieve the fragment.There was a 15 minute delay and the procedure was completed with an alternate unknown device.There was no injury or impact to the (b)(6), male patient.After further assessment it was discovered the fragment was retrieved with a clamp/grasper.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Correction: g1contact phone number was (b)(6) corrected to (b)(6).Manufacturer narrative: reported event is confirmed.To date, the device has not been returned for evaluation, but photographic evidence has been provided that appears to confirm the event.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.(b)(4).Per the instructions for use, the user is advised the following: 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.This issue will continue to be monitored through the complaint system to assure patient safety.H3 other text : device not yet returned.

Event Description

The sales representative reported on behalf of the customer that the device, ks-fgp24, was being used on (b)(6) 2021 during a cross ligament procedure and ¿during the perforation of the femoral tunnel, the malleable wire broke inside the bone.¿ the doctor was able to retrieve the fragment.There was a 15 minute delay and the procedure was completed with an alternate unknown device.There was no injury or impact to the 49 year old, male patient.After further assessment it was discovered the fragment was retrieved with a clamp/grasper.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Corrections: investigation conclusions changed from cause not established to cause traced to user due to evaluation of returned device.Manufacturer narrative: update: reported event is confirmed.Customer complaint of the wire broke inside the bone was confirmed.The returned used device, item ks-fgp24 was evaluated and confirmed the reported problem and found the guide pin broken off.The condition of the returned device shows signs of misuse, the guide pin is bent in the middle of the shaft, due to excessive force.Broken drill tip was returned for the evaluation.Suspect, hard bone was drilled during the tunnel depth.Examination performed could not find any issues with critical dimensions.Reported event is confirmed.To date, the device has not been returned for evaluation, but photographic evidence has been provided that appears to confirm the event.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.(b)(4).Per the instructions for use, the user is advised the following: 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.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 device, ks-fgp24, was being used on (b)(6) 2021 during a cross ligament procedure and ¿during the perforation of the femoral tunnel, the malleable wire broke inside the bone.¿ the doctor was able to retrieve the fragment.There was a 15 minute delay and the procedure was completed with an alternate unknown device.There was no injury or impact to the 49 year old, male patient.After further assessment it was discovered the fragment was retrieved with a clamp/grasper.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: GRAFTMAX FLEX XACTPIN GUIDE PIN
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 12370402
• MDR Text Key: 268238764
• Report Number: 1017294-2021-00326
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: KS-FGP24
• Device Lot Number: 1088940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 10/26/2021; 11/02/2021
• Supplement Dates FDA Received: 10/29/2021; 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic