MAUDE Adverse Event Report: CONMED LARGO 5.5MM HPS PREBENT SPHERICAL BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	HPS-HB11
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the hps-hb11, 5.5mm hps prebent spherical bur, was being used during an hip arthroscopy procedure on (b)(6) 2023 when it was reported, ¿the burr head broke off in the patient's joint, and the doctor was able to retrieve it." there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned with no reported delay.A second bur, hps-hb11, 5.5mm hps prebent spherical bur, was used as a concomitant device; however, the surgeon felt the blade was not working properly and was concerned that the burr head would come apart again.There was no report of the alternate device having any breakage.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the hps-hb11, 5.5mm hps prebent spherical bur, was being used during an hip arthroscopy procedure on (b)(6) 2023 when it was reported, ¿the burr head broke off in the patient's joint, and the doctor was able to retrieve it." there was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed as planned with no reported delay.A second bur, hps-hb11, 5.5mm hps prebent spherical bur, was used as a concomitant device; however, the surgeon felt the blade was not working properly and was concerned that the burr head would come apart again.There was no report of the alternate device having any breakage at the time of usage.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of returned used device item hps-hb11 confirms the reported problem and found 5.5mm bur tip broken off from the inner sleeve.A root cause cannot be determined, however, a possible cause of this event could be that the device was in contact with a metallic or other hard surface.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 shows a total of 7 devices for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised the following: direct contact of the rotating cutting edge of shaver blades and burs with metallic surfaces and/or other hard surfaces such as arthroscopes, cannulas, or other instruments can cause damage to the devices.If contact does occur, shaver blades can break, seize, or shed metal particles.Shaver blade or bur should be examined for damage and replaced if necessary.Do not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.A determination for further investigation has been initiated.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 5.5MM HPS PREBENT SPHERICAL BUR
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18362910
• Report Number: 1017294-2023-00124
• Device Sequence Number: 12765954
• Product Code: GFF
• UDI-Device Identifier: 20845854080518
• UDI-Public: (01)20845854080518(17)281018(10)1349722
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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 Catalogue Number: HPS-HB11
• Device Lot Number: 1349722
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 01/15/2023
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HPS-HB11, 5.5MM HPS SPHERICAL BUR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic