MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE ANGLED HDPC 1:2 F/2.35X70MM; HIGHSPEED POWER SYSTEMS

Model Number GD455R

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with gd455r - micro-line angled hdpc 1:2 f/2.35x70mm.According to the complaint description, the device did not fit with the grinding head.It was found that the grinding head could not be inserted before use / surgery.There was no described patient harm.Additional information has been requested but not yet received as of this report.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: 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 upon the investigations results a capa is not necessary.

Event Description

The malfunction is filed under aag reference (b)(4).

• Brand Name: MICRO-LINE ANGLED HDPC 1:2 F/2.35X70MM
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11448811
• MDR Text Key: 266709764
• Report Number: 9610612-2021-00130
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 04038653074679
• UDI-Public: 4038653074679
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GD455R
• Device Catalogue Number: GD455R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1