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

Model Number	KBR191
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the device, kbr191, infinitytm anteromedial guide r 9/10mm was being used on (b)(6) 2022 during an acl with btb procedure and ¿the end of the guide broke off while being positioned intra-articularly on the patient's femur.Surgeon was able to retrieve the distal portion of the guide, but not the small connecting piece, which was later identified on x-ray.Surgeon plans to reoperate at some point and retrieve it.¿ the procedure was completed with an alternate same device and there was a 10 minute delay to the procedure.Further assessment found the patient was, ¿recovering well and we haven¿t done the second surgery yet.¿.This report is being raised on the basis of injury due to fragment of device remaining in patient.
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Reported event is confirmed.Customer event "end of the guide broke off while being positioned intra-articularly on the patient's femur" was confirmed based on photographic evidence and device evaluation.Examination of the returned used device, item kbr191, lot number 1077642 found device broken off.The tip was broken off from the bullseye shaft at the welding joint location.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 14 reports, regarding 14 devices, for this device family and failure mode.During this same time frame 1,769 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 0.008.Per the instructions for use, the user is advised the following: 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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: INFINITYTM ANTEROMEDIAL GUIDE R 9/10MM
• Common Device Name: 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 13576860
• Report Number: 1017294-2022-00024
• Device Sequence Number: 17276329
• Product Code: LXH
• UDI-Device Identifier: 30845854902329
• UDI-Public: (01)30845854902329(11)200210(10)1077642
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KBR191
• Device Catalogue Number: KBR191
• Device Lot Number: 1077642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic