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	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
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 on (b)(6) 2023 and "we had an issue today with a new conmed surgeon.We had 2 of the products above break in one case back-to-back.Was using the burr in accordance to how it is intended to be used and had to open up other companies burrs instead of ours to finish the case.Both were the same lot number¿.Per further assessment it was found that "the device did break into the surgical field and all components were removed from the field.".There was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of the bur breaking off is confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.The root cause cannot be determined, however, based upon the photo and the ifu the likely cause of this event was excessive force was used on the device.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.(b)(4).Per the instructions for use, the user is advised the following: 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.
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 on (b)(6) 2023 and "we had an issue today with a new conmed surgeon.We had 2 of the products above break in one case back-to-back.Was using the burr in accordance to how it is intended to be used and had to open up other companies burrs instead of ours to finish the case.Both were the same lot number¿.Per further assessment it was found that "the device did break into the surgical field and all components were removed from the field." there was no report of impact/injury, medical intervention or prolonged hospitalization to the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 18265674
• Report Number: 1017294-2023-00112
• Device Sequence Number: 7890683
• Product Code: GFF
• UDI-Device Identifier: 20845854080518
• UDI-Public: (01)20845854080518(17)281018(10)1349722
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/08/2024

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic