MAUDE Adverse Event Report: CONMED LARGO INFINITY RETRO-REAMER, 9MM; BIT, SURGICAL

Catalog Number KRR090

Device Problem Material Fragmentation (1261)

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

Event Date 10/17/2021

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the krr090, infinity retro-reamer, 9mm device was being used on (b)(6) 2021 during an lca procedure when it was reported ¿the surgery of lca was performed with infiniti button procedure, entering with the guide 3.5 first, it was passed to use the retrograde bit infiniti of 9 which normal step at the time of unlocking the bit we realized that the fin was activated being broken inside the patient a part remaining in soft which could be removed with the help of a grasper and the other inside the bone that was observed with x-rays proceeded to use a second bit to finish the tunnel where the graft would enter at the end was sucked with the shaver the area where it was used if the small surplus of the bit came out leaving with its entirety.¿ there was no report of impact/injury to the patient.The procedure was completed with an alternate unknown device.Further assessment has been sent; however, to date no response has been received.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Reported event is confirmed.Customer event ¿broken inside the patient¿ was confirmed based on photographic evidence.To date, the device has not been returned for evaluation, but photographic evidence has been provided that confirmed the reported issue.A two-year lot history review cannot be conducted as no lot number was provided.A device history review cannot not be conducted as no lot number was provided.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) 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 the following: 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor reported on behalf of their customer that the krr090, infinity retro-reamer, 9mm device was being used on (b)(6) 2021 during an lca procedure when it was reported ¿the surgery of lca was performed with infiniti button procedure, entering with the guide 3.5 first, it was passed to use the retrograde bit infiniti of 9 which normal step at the time of unlocking the bit we realized that the fin was activated being broken inside the patient a part remaining in soft which could be removed with the help of a grasper and the other inside the bone that was observed with x-rays proceeded to use a second bit to finish the tunnel where the graft would enter at the end was sucked with the shaver the area where it was used if the small surplus of the bit came out leaving with its entirety.¿ there was no report of impact/injury to the patient.The procedure was completed with an alternate unknown device.Further assessment has been sent; however, to date no response has been received.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: INFINITY RETRO-REAMER, 9MM
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 12865110
• MDR Text Key: 282516298
• Report Number: 1017294-2021-00362
• Device Sequence Number: 1
• Product Code: GFG
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KRR090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic