MAUDE Adverse Event Report: CONMED LARGO 3.5MM SPADE TIP GUIDE PIN; BIT, SURGICAL

Catalog Number	KGP035
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of a customer that the device, kgp035, 3.5mm spade tip guide pin, was in use in an acl reconstruction procedure on (b)(6) 2023, and, ¿when they were performing the femoral tunel, the tip of the kgp035 broke in the first cortical, leaving the tip into the joint.The surgeon had to remove it, delaying the surgery, and making the situation a little stressful¿.The procedure was completed with an alternate same device, with a reported delay of 15 minutes.There is no report of medical intervention or prolonged hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.A device history record (dhr) review found a non-conformance; however, it was not related to the reported event.A two-year lot history review shows this is the only event for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised the following: avoid damage or breakage during use, do not use excessive force on guide pin.Do not use the guide pin to pry.Inspect pin prior to use and after removal to ensure it is in good physical condition.Do not bend the guide pin prior to or during insertion.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of a customer that the device, kgp035, 3.5mm spade tip guide pin, was in use in an acl reconstruction procedure on (b)(6) 2023, and, ¿when they were performing the femoral tunel, the tip of the kgp035 broke in the first cortical, leaving the tip into the joint.The surgeon had to remove it, delaying the surgery, and making the situation a little stressful¿.The procedure was completed with an alternate same device, with a reported delay of 15 minutes.There is no report of medical intervention or prolonged hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: 3.5MM SPADE TIP GUIDE PIN
• Common Device Name: 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18438275
• Report Number: 1017294-2024-00001
• Device Sequence Number: 15209761
• Product Code: GFG
• UDI-Device Identifier: 20845854648978
• UDI-Public: (01)20845854648978(17)280524(10)1319706
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: KGP035
• Device Lot Number: 1319706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic