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	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, hps-hb11, 5.5mm hps prebent spherical bur, was being used during a hip arthroscopy, cam resection on (b)(6) 2023, and ¿we had 2 hps-hb11 burs malfunction in the same case this morning.The first bur was ¿skipping or stalling¿ while the foot pedal was completely pressed.We switched the bur out with another one of the same lot number and it began doing the same thing.The surgeon kept using it and the head of the bur broke off inside the hip on the cam resection.He was able to remove it quickly with no significant delay.¿ the procedure was completed with an alternate same device.Further assessment confirmed that there was no injury, medical or surgical intervention for the patient or user, and no extended hospital stay was required for the patient.The patient is reportedly doing well.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of returned used device found the bur tip broken off from the inner sleeve.Broken bur was returned for the evaluation.These observations would indicate that excessive force at the bur tip can cause this failure.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 however, only 1 device is confirmed.(b)(4).Per the instructions for use, the user is advised to 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.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 device, hps-hb11, 5.5mm hps prebent spherical bur, was being used during a hip arthroscopy, cam resection on (b)(6) 2023, and ¿we had 2 hps-hb11 burs malfunction in the same case this morning.The first bur was ¿skipping or stalling¿ while the foot pedal was completely pressed.We switched the bur out with another one of the same lot number and it began doing the same thing.The surgeon kept using it and the head of the bur broke off inside the hip on the cam resection.He was able to remove it quickly with no significant delay.¿ the procedure was completed with an alternate same device.Further assessment confirmed that there was no injury, medical or surgical intervention for the patient or user, and no extended hospital stay was required for the patient.The patient is reportedly doing well.This report is being raised on the basis of 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 18277197
• Report Number: 1017294-2023-00113
• Device Sequence Number: 6667838
• Product Code: GFF
• UDI-Device Identifier: 20845854080518
• UDI-Public: (01)20845854080518(17)281018(10)1349722
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/12/2024
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic