MAUDE Adverse Event Report: AESCULAP, INC. ELAN 4 1-RING DIAMOND BURR X-COARSE D6.0; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	GP176R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Exemption number: e2014018.Evaluation on-going.
Event or Problem Description
It was reported to aesculap (b)(4) that an elan 4 1-ring diamond burr x-coarse d7.0 (part # gp177r) (ref.Associated mdr id 2916714-2016-01047), an elan 4 1-ring diamond burr x-coarse d6.0 (part # gp176r), an elan 4 1-ring diamond burr coarse d4.0 (part # gp168r) (ref.Associated mdr id 2916714-2016-01049), and an elan 4 1-ring diamond burr coarse d5.0 (part # gp169r) (ref.Associated mdr id 2916714-2016-01050), were used during an ears, nose and throat (ent) procedure.According to the complainant, diamond grains were observed falling from the device burrs into the operating area.The surgeon immediately observed the grains through the microscope and removed them from the site.No known patient complications occurred as a result of the event.
Additional Manufacturer Narrative
The product was cleaned.No signs of usage can be found at the shaft.Blank areas without diamond-coating are recognizable.The investigation was carried out by the supplier.The returned part has been observed.The bar has lost some of the diamond grits by places.Analyzed by our manufacturing department, the nickel layer which maintains the diamond grits turns out to have a low thickness according to our internal prescriptions (diamond grits are covered by less that two-thirds of nickel).Despite the fact that the nickel thickness is not a feature specified on the drawings, manufacturing department estimated the current parameters followed during the manufacturing of such burs using grit size 501 should be reviewed as revalidated.They recommended the opening of a capa to handle this issue.The device quality and manufacturing history records has been checked by the supplier for the available lot number.The device history file has been checked and found to be according to the specification of the supplier valid at the time of production.Based on the information available as well as a result of the investigation of the supplier the root cause of the failure is most probably a manufacturing error.The supplier will open a capa in order to implement the needed corrective action.

• Brand Name: ELAN 4 1-RING DIAMOND BURR X-COARSE D6.0
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grun ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 6586458
• Report Number: 2916714-2016-01048
• Device Sequence Number: 3033774
• Product Code: HBE
• UDI-Device Identifier: 04046964558863
• UDI-Public: 4046964558863
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K182527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: GP176R
• Device Catalogue Number: GP176R
• Device Lot Number: 52267748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: 11/11/2016
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 05/23/2017
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown