MAUDE Adverse Event Report: AESCULAP AG ELAN 4 1-RING DIAMOND BURR D5.0; DRILL BURR

Model Number GP157R

Device Problem Particulates (1451)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation results: the returned device was contaminated.At initial visual exam, no obvious damage was noted.The burr was heavily soiled with bone residues and flaws of the diamonds were not visible.The burr was cleaned for one hour with "helizyme" and then cleaned with a water pistol and dried with compressed air.During visual inspection, clear bone remains were noted, so the burr head was brushed with a soft brush, the burr was then cleaned with water and dried with compressed air again.There were no signs of wear on the shaft.There were no traces of wear on the cutter coupling.There were no defects in the diamonds noted.The device history records for the reported lot number (52471949) were reviewed and found to be according to specification valid at the time of production.There is no indication for a material or manufacturing defect.No further complaints have been registered against this lot number.The heavy abrasion reported by the customer can not be confirmed.The failure may be related to wear and tear.The burr head of the diamond cutter shows normal wear, with no extraordinary grain loss noted.A minimal grain loss cannot be prevented.This is found in the instructions for use (ifu).The diamond cutter could still be used.According the warning in the ifu: danger of injury from foreign body reactions (e.G.Inflammation, encapsulation) if particles remain in the body! when using diamond tools, it is always possible for diamond grains/nickle particles to break away/off.Carefully rinse and vacuum while and after working with diamond tools.

Event Description

It was reported that there was heavy abrasions/shavings of the drilling burr, which were deposited in the patient's tissue.The surgeon had difficulty removing all of the shavings.It is reported that x-ray was most likely taken.Additional information has been requested, however has not been provided at the time of this report.

• Brand Name: ELAN 4 1-RING DIAMOND BURR D5.0
• Type of Device: DRILL BURR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8210188
• MDR Text Key: 131853027
• Report Number: 9610612-2019-00005
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: GP157R
• Device Catalogue Number: GP157R
• Device Lot Number: 52471949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Distributor Facility Aware Date: 12/18/2018
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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
• Patient Outcome(s): Required Intervention