MAUDE Adverse Event Report: AESCULAP AG ELAN 4 MIS L13 DISP.DIAMOND BURR D3.0; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	GP452SU
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that an elan 4 mis l13 disp.Diamond burr d3.0 (part # gp452su) was used during a procedure performed on (b)(4) 2021.According to the complainant, while performing a clinical evaluation in theatre, the surgeon had been burring for approximately ten (10) minutes at 80,000 rotations per minute (rpm) using the elan 4 mis handpiece from an elsa set.The drill suddenly stopped working and the distal end dropped out of the mis handpiece shaft.As the burr was changed, the first burr came out in two pieces as it had snapped in two.A slight surgical delay of approximately thirty (30) seconds was reported.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation: visual investigation carried out pictorial documentation visually and microscopically.The product is visibly in a good condition.On the burr head are no signs of wear and tear.Furthermore, the record of the burr is without any scratch marks.Approximately in the middle, the shaft is broken.We assume it was broken by handling and overload.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.The review of risk assessment revealed that the overall risk level (3(5)severity x 2(5)probability of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: based on the information available as well as a result of our investigation the root cause of the faliure is most probably related to an overloading and handling.Conclusion and root cause: due to the current deviation, and according to explanation above, the root cause of the problem is most probably usage-related.A capa is not necessary.

• Brand Name: ELAN 4 MIS L13 DISP.DIAMOND BURR D3.0
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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: 12149946
• Report Number: 9610612-2021-00498
• Device Sequence Number: 4660564
• Product Code: HBE
• UDI-Device Identifier: 04046964725975
• UDI-Public: 4046964725975
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2026
• Device Model Number: GP452SU
• Device Catalogue Number: GP452SU
• Device Lot Number: 52662805
• 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: 06/19/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown