• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG TWIST DRILL 2MM DIA NSTRUMENTS FOR NEUROSURGERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AESCULAP AG TWIST DRILL 2MM DIA NSTRUMENTS FOR NEUROSURGERY Back to Search Results
Model Number FF068R
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 07/23/2019
Event Type  Injury  
Manufacturer Narrative

Manufacturing site evaluation: the drill ff068r is available for investigation decontaminated according to the internal standards. The broken off working end is missing. Additionally we received a broken gc004r. A request has been placed to clarify to which incident this drill must be attributed. Vigilance investigator carried out the pictorial documentation visually and microscopically. No pores, inclusions or foreign bodies could be found on the point of rupture. Small brownish spots can be recognized on the fracture pattern, presumably caused by the processing after the breakage. The product does not require batch management; a review of the device quality and manufacturing history records is not possible. The breakage of the drill was most likely caused by an overload situation, presumable caused by tumbling during application. For example during application with a hudson brace hand drill.

 
Event Description

It was reported that there was an issue with a twist drill 2mm dia. According to the complaint description: "when a brain pressure probe was applied, the drill broke off and became partially stuck in the skull bone. The broken part had to be removed from the bone. The patient had to be transported to the operating room and a small craniectomy had to be performed. " the adverse event/malfunction is filed under (b)(4.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTWIST DRILL 2MM DIA
Type of DeviceNSTRUMENTS FOR NEUROSURGERY
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
kerstin rothweiler
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key8920873
MDR Text Key155209183
Report Number9610612-2019-00576
Device Sequence Number1
Product Code HTW
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberFF068R
Device Catalogue NumberFF068R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/12/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/22/2019 Patient Sequence Number: 1
-
-