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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
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.Device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, kbr191, infinitytm anteromedial guide r 9/10mm was being used on (b)(6) 2022 during an anterior cruciate ligament reconstruction procedure and ¿instrument broke during surgery¿.There was no injury to the patient or user reported.There was also no report of medical intervention or hospitalization for this event.The procedure was completed with an alternate infinity guide.Further assessment found there was no delay to the procedure and the device broke with no contact to the patient.The patient status was reported as having ¿no issues.¿ this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported event of ¿instrument broke during surgery¿ is confirmed.The device will not be returned for evaluation; however, the provided photographic evidence exhibits the reported 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.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 1,827 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 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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, kbr191, infinitytm anteromedial guide r 9/10mm was being used on 22feb22 during an anterior cruciate ligament reconstruction procedure and ¿instrument broke during surgery¿.There was no injury to the patient or user reported.There was also no report of medical intervention or hospitalization for this event.The procedure was completed with an alternate infinity guide.Further assessment found there was no delay to the procedure and the device broke with no contact to the patient.The patient status was reported as having ¿no issues¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: 13861054
• Report Number: 1017294-2022-00038
• Device Sequence Number: 14619259
• Product Code: LXH
• UDI-Device Identifier: 30845854902329
• UDI-Public: (01)30845854902329(11)200609(10)1100692
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: KBR191
• Device Catalogue Number: KBR191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic