MAUDE Adverse Event Report: AESCULAP AG ELAN 4 2-RING TWIST DRILL D1.5; HIGHSPEED POWER SYSTEMS

Model Number	GP348R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
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 a elan 4 2-ring twist drill d1.5 (part # gp348r) was used during a cranial formation procedure performed on (b)(6) 2021.According to the complainant, the bar blade was broken.In order to restore the skull flap of the autologous bone that had been frozen, the doctor tried to make a hole by attaching a twist drill to the craniotome when tenting the skull flap.However, the bar was broken.The physician continued and successfully completed the procedure using a different device.The complaint device was 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 results: visual investigation: the fragments have been analyzed visually.The reported breakage can be confirmed.The drill broke approx.14mm from the tip.The fracture surface has been analyzed optically via microscope.There is no indication for a materila failure.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.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.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: based on the provided information and after the investigation, a clear conclusion cannot be drawn.There is no indication for a material problem or product failure.Hence, we suspect that an overload situation led to the breakage.The reported intraoperative second breakage of another drill may also indicate a difficult surgery situation.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.Based upon the investigations results a capa is not necessary.

• Brand Name: ELAN 4 2-RING TWIST DRILL D1.5
• 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: 12820700
• Report Number: 9610612-2021-00721
• Device Sequence Number: 5696333
• Product Code: HBE
• UDI-Device Identifier: 04046964560385
• UDI-Public: 4046964560385
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172709
• 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): 03/03/2022

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 Model Number: GP348R
• Device Catalogue Number: GP348R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male