MAUDE Adverse Event Report: AESCULAP AG CRANIAL PERFORATOR 9/12MM HUDSON SHANK; TOOLS FOR HIGH SPEED POWER SYSTEMS

Model Number GB302R

Device Problem Failure to Auto Stop (2938)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that the trepane doesn't stop automatically.

Manufacturer Narrative

Investigation: the investigation has been carried out by the ats department.Optically, damages and impact marks can be found at the outer and inner cutting edges of the mill.The shaft of the perforator is in good condition and the release function is given with a new mill.In combination with the complained mill, high forces are necessary, therefore a correct release of the perforator is not possible.The reason for that are the damaged cutting edges.These damages are most likely attributed to an incorrect handling or improper storage.Batch history review: the device history file has been checked and found to be according to specification, valid at the time of production.There is no indication of a material defect or a manufacturing error.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably user related due to an incorrect handling or an insufficient maintenance of the device.No capa in necessary.

• Brand Name: CRANIAL PERFORATOR 9/12MM HUDSON SHANK
• Type of Device: TOOLS FOR HIGH SPEED 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6567585
• MDR Text Key: 75316100
• Report Number: 9610612-2017-00267
• Device Sequence Number: 1
• Product Code: MVA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/11/2017
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other