MAUDE Adverse Event Report: CONMED LARGO INFINITY RETRO-REAMER, 10MM; BIT, SURGICAL

Model Number	KRR100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
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.
Event or Problem Description
The sales representative reported on behalf of the customer that the krr100, infinity retro-reamer, 10mm was being used during an acl reconstruction on (b)(6) 2022 when it was reported that the ¿reamer tip shattered inside patient when retro reaming the femoral socket.The doctor had to fish out 2 pieces of the tip from inside the joint.¿ the procedure was completed with report of a 10-minute delay to the case.Further assessment found the reamer tip was removed from inside the joint using a grasper.There was no injury to the patient and no medical intervention or extended hospitalization was required for the patient.The patient is said to be okay and unharmed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the krr100, infinity retro-reamer, 10mm was being used during an acl reconstruction on (b)(6) 22 when it was reported that the ¿reamer tip shattered inside patient when retro reaming the femoral socket.The doctor had to fish out 2 pieces of the tip from inside the joint.¿ the procedure was completed with report of a 10-minute delay to the case.Further assessment found the reamer tip was removed from inside the joint using a grasper.There was no injury to the patient and no medical intervention or extended hospitalization was required for the patient.The patient is said to be okay and unharmed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: d4.Lot number was corrected from 1232757 to lot number:1230761 as new information was provided since initial filing.Manufacturer narrative: customer event ¿reamer tip shattered inside patient¿ was confirmed based on photographic evidence and device evaluation.Visual examination of the returned device item krr100, found device broken off at the tip, broken piece was not returned for evaluation.Also, evaluation found reamer cap broken off.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.A two-year lot history review was conducted and found a total of 2 similar events involving 2 devices for this lot number.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 5 devices, for this device family and failure mode.During this same time frame (b)(4).Per the instructions for use, the user is advised 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.Exercise care in the use of the handpiece holding the reamer to minimize side or bending loads to the reamer which may cause reamer breakage and/or oversized tunnels.Excessive force applied during retrograde drilling can lead to reduced socket sizes.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: INFINITY RETRO-REAMER, 10MM
• 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: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 14955694
• Report Number: 1017294-2022-00077
• Device Sequence Number: 5459794
• Product Code: GFG
• UDI-Device Identifier: 20845854902025
• UDI-Public: (01)20845854902025(17)230828(10)1230761
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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 Expiration Date: 08/28/2023
• Device Model Number: KRR100
• Device Catalogue Number: KRR100
• Device Lot Number: 1230761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic