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

Catalog Number HPS-HB11

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

The hps prebent spherical bur was received for an evaluation.A visually inspection of the returned device and verified the distal tip of bur broke off.Further analysis by the quality engineer found the sleeve was sheared at the weld location, detaching the bur tip from the device.Additional testing by the r&d engineer could not replicate this failure.This lot with the udi# (b)(4) was manufactured on 29-jan-2016.Of the lot containing (b)(4), there have been no other complaints received for this item and lot number combination.A 2-year review of complaint history shows there have been (b)(4) reports of "head of bur breaking off" received for this product family.During this same time frame, approximately (b)(4).To date, there have been no patient long term adverse effects resulting from this type of incident.This failure mode is addressed in the dfmea, and the safety risk has been found to be acceptable.(b)(4) blades and burs are made primarily of stainless steel.The intended use of these blades and burs is for cutting and removing soft tissue, or bone, from a patient during procedures.To reduce the risk of patient injury, the instructions for use (ifu) provides the following operating instructions and precautions: this equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment; 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; 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 blades or burs 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 caused damage to the device including permanent deformation, shedding of metal(wear), motor seizure, and overheating.

Event Description

The user facility reported that during a hip arthroscopy w/labral repair, osteoplasty, acetabular rim trim procedure, the distal tip of this 5.5mm hps prebent spherical bur broke off and fell into the surgical site.The piece was immediately retrieved.After a 2 minute delay, the surgery was successfully completed using another hps-hb11 bur with no further issues.No patient injury was reported.To date, there has been no additional information received regarding the patient's latest condition or any indication that a long term adverse effect has occurred.

• Brand Name: 5.5MM HPS PREBENT SPHERICAL BUR
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5895126
• MDR Text Key: 53667586
• Report Number: 1017294-2016-00090
• Device Sequence Number: 1
• Product Code: GFF
• 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,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Catalogue Number: HPS-HB11
• Device Lot Number: 711069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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