MAUDE Adverse Event Report: CONMED LARGO XACTPIN GRAFT PASSING GUIDE PIN STER; BIT, SURGICAL

Model Number C8677S

Device Problem Material Fragmentation (1261)

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

Event Date 02/11/2022

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the device, c8677s, xactpin graft passing guide pin ster was being used on (b)(6) 2022 during an acl procedure and ¿the surgeon advanced the eyelet drill guide c8677s passed the lateral femoral cortex.She backed it up in order to take the measure and the drill guide broke.¿ there was no injury or impact to the patient.The procedure was completed with an alternate same device.There was a 30 minute delay.Further assessment found ¿the guide pin broke into the joint.The surgeon found the tips on the lateral of the femur using c-arm.She removed the remaining fragment of the guide.¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

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.

Manufacturer Narrative

Reported event is confirmed.Customer event ¿drill guide broke¿ was confirmed based on photographic evidence and device evaluation.The evaluation of returned used device, item c8677s, found guide pin broken off at the etch line.Broken guide was return for evaluation.Critical dimensions were inspected per print c8677s and could not find any discrepancies.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 two reports, regarding three devices, for this device family and failure mode.During this same time frame 1,938 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 0.002.Per the instructions for use, the user is advised the following: to avoid damage or breakage during use, do not use excessive force on xactpin graft passing guide pin - sterile.Inspect pin 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 xactpin graft passing guide pin - sterile prior to or during insertion.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, c8677s, xactpin graft passing guide pin ster was being used on 11feb22 during an acl procedure and ¿the surgeon advanced the eyelet drill guide c8677s passed the lateral femoral cortex.She backed it up in order to take the measure and the drill guide broke.¿ there was no injury or impact to the patient.The procedure was completed with an alternate same device.There was a 30 minute delay.Further assessment found ¿the guide pin broke into the joint.The surgeon found the tips on the lateral of the femur using c-arm.She removed the remaining fragment of the guide.¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: XACTPIN GRAFT PASSING GUIDE PIN STER
• 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: 13585516
• MDR Text Key: 286359245
• Report Number: 1017294-2022-00026
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 10845854041741
• UDI-Public: (01)10845854041741(17)250108(10)1071456
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

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 Model Number: C8677S
• Device Catalogue Number: C8677S
• Device Lot Number: 1071456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: X-RAY; X-RAY
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic