MAUDE Adverse Event Report: CONMED LARGO INFINITYTM ANTEROMEDIAL GUIDE R 7/8MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number KBR178

Device Problem Material Fragmentation (1261)

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

Event Date 06/09/2021

Event Type  malfunction  

Manufacturer Narrative

The reported event of ¿the device came apart where the two pieces are connected¿ is confirmed.Visual examination of the returned used device found the machined tip detached from the bullseye shaft.Detached tip was not returned for evaluation.No sign of misuse found with returned device.A device history review found no abnormalities that would contribute to this issue.Although this is a reusable device, it is not serviceable; therefore, a service history is not available for review.(b)(4).Per the instructions for use, the user is advised the following: do not use excessive force on instrument to avoid damage or breakage during use.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the device, kbr178, was being used on (b)(6) 2021 during an unknown procedure and the ¿the unit just comes apart where the two pieces are connected.¿ there was no injury/impact to the patient.After further assessment, it was found that the fragments did fall into the surgical site and were retrieved with a grasper.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: INFINITYTM ANTEROMEDIAL GUIDE R 7/8MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• MDR Report Key: 12411199
• MDR Text Key: 280606003
• Report Number: 1017294-2021-00334
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 30845854902312
• UDI-Public: (01)30845854902312(11)191125(10)1062755
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial
• Report Date: 09/01/2021

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
• Device Operator: Health Professional
• Device Model Number: KBR178
• Device Catalogue Number: KBR178
• Device Lot Number: 1062755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 09/01/2021
• Patient Sequence Number: 1