MAUDE Adverse Event Report: AESCULAP AG CRANIAL PERFORATOR 9/12MM HUDSON SHANK; HIGHSPEED POWER SYSTEMS

Model Number GB302R

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a cranial perforator 9/12mm hudson shank (part # gb302r) was used during a procedure performed on an unknown date.According to the complainant, during the procedure, the drill did not stop after piercing the skull.The complaint device has not been returned to the manufacturer for evaluation.No patient complications have been reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: product was not provided.Therefore, no failure description or investigation possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records (dhr) 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.Explanation and rationale: based on the provided information and without a product for investigation, a clear conclusion cannot be drawn.A dhr review must remain incomplete due to a lack of the lot number.Experience wise, it is possible that the release mechanism was faulty due to damaged/blunt cutting edges.However, this is only speculative.Several information regarding functional checks / inspection of such a perforator, can be found within the corresponding instructions for use (ifu): potential impairments include ->blunt cutting edges and incorrectly sharpened inner and outer drill cutting edges -> mechanical damage to the cutting edges fo the inner and out drill in particular -> wear and tear or damage to the coupling dogs on the inner drill and lock head -> inadequate preparation (do not use the product if it is damaged or defective) conclusion and measures / preventive measures: based upon the investigation results, an exact cause cannot be determined at this moment.Based upon the investigations results a capa is not necessary.

• Brand Name: CRANIAL PERFORATOR 9/12MM HUDSON SHANK
• Type of Device: 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: 12800412
• MDR Text Key: 281511729
• Report Number: 9610612-2021-00734
• Device Sequence Number: 1
• Product Code: HSZ
• UDI-Device Identifier: 04038653069545
• UDI-Public: 4038653069545
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB302R
• Device Catalogue Number: GB302R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1