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

Model Number KRR100

Device Problem Material Fragmentation (1261)

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

Event Date 04/08/2023

Event Type  malfunction  

Event Description

The distributor reported on behalf of their customer that the krr100, infinity retro-reamer, 10mm, was being used during a reconstruction acl allinside procedure on (b)(6)23 when it was reported ¿the cutting tip is broken¿.Further assessment questioning found that ¿the tip was recovered.It came out still attached to the drill bit¿.The procedure was completed with a 10-minute delay and the use of an alternate retro drill device.There was no report of injury, medical intervention, or hospitalization for the patient or user.The current status of the patient was reported as ¿unknown, no news reported¿.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

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 distributor reported on behalf of their customer that the krr100, infinity retro-reamer, 10mm, was being used during a reconstruction acl allinside procedure on (b)(6) 2023 when it was reported ¿the cutting tip is broken.¿.Further assessment questioning found that ¿the tip was recovered.It came out still attached to the drill bit.¿.The procedure was completed with a 10-minute delay and the use of an alternate retro drill device.There was no report of injury, medical intervention, or hospitalization for the patient or user.The current status of the patient was reported as ¿unknown, no news reported.¿.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The returned used device, item krr090 was evaluated per print (b)(4) and confirm the reported problem.Reamer found broken off at the tip.Broken piece was returned for evaluation.The probable cause for this is the application of too much force.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 12 complaints, regarding 13 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised not to 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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: INFINITY RETRO-REAMER, 10MM
• Type of Device: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17146027
• MDR Text Key: 317343008
• Report Number: 1017294-2023-00054
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 20845854083540
• UDI-Public: (01)20845854083540(17)240128(10)1262022
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2024
• Device Model Number: KRR100
• Device Catalogue Number: KRR100
• Device Lot Number: 1262022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic