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

Catalog Number HPS-HB11

Device Problem Peeled/Delaminated (1454)

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

Event Date 02/26/2021

Event Type  malfunction  

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the device, hps-hb11, was being used during a hip arthroscopy procedure on (b)(6) 2021 when "the blades stucked until short time.There was plastic abrasion in the joint which was removed." the procedure was completed with an alternate same device.There was a 15 minute delay.There was no report of injury, medical intervention or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Customer event "blades stucked until short time.There was plastic abraison in the join which was removed" was confirmed based on photographic evidence and device evaluation.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 was conducted and found a total of 2 similar events involving 5 devices for this lot number.A two-year review of complaint history revealed there has been a total of 11 complaints, regarding 5 devices, for this device family and failure mode.During this same time frame 9,425 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0005.Per the instructions for use, the user is advised the following: it is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories.Do not use shaver blade or bur if they show any signs of damage.Handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.Prior to each use, perform the following: ensure all accessories are correctly and completely attached.Perform the required preoperative functional tests for the equipment and accessories.Always inspect for bent, dull or damaged blades or burs before use.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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 5.5MM HPS PREBENT SPHERICAL BUR
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 11487816
• MDR Text Key: 244007850
• Report Number: 1017294-2021-00126
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HPS-HB11
• Device Lot Number: 1128021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 04/22/2021
• Patient Sequence Number: 1