MAUDE Adverse Event Report: AESCULAP AG ELAN 4 MIS L13 DISP.DIAMOND BURR D4.0; HIGHSPEED POWER SYSTEMS

Model Number	GP453SU
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to aesculap (b)(4) that an elan 4 mis l13 disp.Diamond burr d4.0 (part # gp453su) was used during a procedure performed on (b)(6) 2022.According to the complainant, the bar was broken.When this product was used on the base of the skull, three consecutive events occurred that broke every 10 minutes of use.Used for ga860 + gb927r.When the first one was broken, the doctor pressed the tip against the bone and thought it was the cause of the break.Therefore, after that, it was used with care not to press it too much, but it broke with the second and third ones.It is said that all the broken parts were on the ga860 side from the center of the shaft.There was no described patient harm.Although requested, additional information has not been made available.The malfunction is filed under aesculap (b)(4) reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based on the investigation results, a capa is not required.

• Brand Name: ELAN 4 MIS L13 DISP.DIAMOND BURR D4.0
• Common Device Name: HIGHSPEED POWER SYSTEMS
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13795203
• Report Number: 9610612-2022-00059
• Device Sequence Number: 11753939
• Product Code: HBE
• UDI-Device Identifier: 04046964725999
• UDI-Public: 4046964725999
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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 Model Number: GP453SU
• Device Catalogue Number: GP453SU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown