MAUDE Adverse Event Report: CONMED LARGO INFINITYTM ANTEROMEDIAL GUIDE L 9/10MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number KBL191

Device Problem Material Fragmentation (1261)

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

Event Date 07/13/2023

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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text: device not yet received.

Event Description

The sales representative reported on behalf of the customer, that the kbl191, infinitytm anteromedial guide l 9/10mm was being used during an acl procedure on (b)(6) 2023, when it was reported.¿dr.Was about to drill the 3.5mm spade tip pin (kgp035) while using the 9/10mm femoral offset guide (kbl191).As he went to hook the back of the femoral condyle, the guide tip broke off inside the patient.Dr.Was able to retrieve all the broken pieces and the procedure was finished without injury to the patient by drilling the pin freehand.¿ the procedure was completed without the use of an alternate device.There was also a 5-minute delay reported.There was no report of injury, medical intervention, or extended hospitalization to the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer, that the kbl191, infinitytm anteromedial guide l 9/10mm was being used during an acl procedure on (b)(6) 2023 when it was reported ¿dr.Was about to drill the 3.5mm spade tip pin (kgp035) while using the 9/10mm femoral offset guide (kbl191).As he went to hook the back of the femoral condyle, the guide tip broke off inside the patient.Dr.Was able to retrieve all the broken pieces and the procedure was finished without injury to the patient by drilling the pin freehand.¿.The procedure was completed without the use of an alternate device.There was also a 5-minute delay reported.There was no report of injury, medical intervention, or extended hospitalization to the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

An evaluation of the returned device found that the tip of the guide broke off.The broken piece was not returned for evaluation.The evaluation was performed per print p000025631 rev.E.While a root cause cannot be determined, a likely cause was the application of excessive force during use which is identified in the ifu.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 9 complaints, regarding 9 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 (b)(4).Per the instructions for use, the user is advised to inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken, or misaligned parts.Inspect instruments following use to ensure device integrity is intact.There should be no loose, broken, or missing parts.Do not use excessive force on instruments to avoid damage or breakage during use.Do not use instruments to pry, as bending or breakage may occur.Do not use improperly or with excessive force, as accuracy may be compromised.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: INFINITYTM ANTEROMEDIAL GUIDE L 9/10MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17395578
• MDR Text Key: 320047776
• Report Number: 1017294-2023-00069
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 30845854902305
• UDI-Public: (01)30845854902305(11)200227(10)1076021
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KBL191
• Device Lot Number: 1076021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic