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

Catalog Number HPS-HB12

Device Problems Disconnection (1171); Device Inoperable (1663)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/03/2015

Event Type  No Answer Provided  

Manufacturer Narrative

As of this filing, the damaged bur has been returned/received from the user facility for evaluation.The investigation remains in process.A supplemental and final report will be filed upon the completion of the investigation.

Event Description

The surgeon reported that while using the 5.5mm hps prebent polishing bur in a hip surgery on (b)(6) 2015, the bur head was not functioning correctly.When the surgeon stopped running the bur, it was discovered that the head had disconnected from the inner tube and had fallen into the patient and landed on a piece of bone.Using graspers, the surgeon carefully removed the broken bur head from the patient's joint.This event contributed to a 30-minute delay during the procedure.The procedure was completed as intended with no further complications or patient injury.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.

Manufacturer Narrative

Conmed received the damaged bur for evaluation.Visual inspection of the returned instrument confirmed the reported breakage.Viewed under magnification, the returned bur shows evidence of a torsional failure below the sleeve-to-bur weld location.A design evaluation protocol and report was completed that included testing samples of this device from the same lot number to recreate the failure.Testing was completed with no non-conformances or failures.This device was manufactured on august 5, 2015 in a lot of 60 units.(b)(4).A review of the device history record showed no anomalies or non-conformances during the manufacturing process that could have caused or contributed to the reported breakage.There have not been any other adverse events reported for this device.There have not been any other complaints reported for this device and lot number combination.This failure mode is addressed in the fmea, and the safety risk has been found to be acceptable.This event is considered an unusual event as this particular failure has not previously been seen.

• Brand Name: 5.5MM HPS PREBENT POLISHING BUR
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5180331
• MDR Text Key: 29349289
• Report Number: 1017294-2015-00055
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: HPS-HB12
• Device Lot Number: 577800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1