MAUDE Adverse Event Report: CONMED CORPORATION 5.5MM HPS PREBENT POLISHING BUR; BURS/SHAVERS

Catalog Number HPS-HB12

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Complaint confirmed.Evaluation and visual inspection of the returned used bur hub, item hps-hb12, qty of two(2) confirmed the reported problem, and found outer bur melted and the outer tube damage, due to excessive force applied during case.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 were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been 7 complaints regarding 8 devices for this device family and failure mode.(b)(4).Per the instructions for use, the user is advised the following; always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The conmed representative reported on behalf of the customer that the, hps-hb12, 5.5mm hps prebent polishing bur appeared to have melted at the hub and metal shavings were seen in the surgical site on (b)(6) 2019 during a hip arthroscopy.The metal shavings were washed out.There is no reported patient injury or impact.There was a slight delay to get another hand piece.The procedure was completed as planned.This report is being raised based on device malfunction with potential for injury upon reoccurrence.

• Brand Name: 5.5MM HPS PREBENT POLISHING BUR
• Type of Device: BURS/SHAVERS
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• Manufacturer Contact: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8666641
• MDR Text Key: 151946402
• Report Number: 1017294-2019-00061
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 20845854080525
• UDI-Public: (01)20845854080525(17)240107(10)989093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Catalogue Number: HPS-HB12
• Device Lot Number: 989093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1