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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ACCULAN 3TI DRILL AND REAMER POWER SYSTEMS

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AESCULAP AG ACCULAN 3TI DRILL AND REAMER POWER SYSTEMS Back to Search Results
Model Number GA672
Device Problem Mechanical Problem (1384)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 05/20/2020
Event Type  Injury  
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 product acculan 3 ti drill. It was reported that during a hip prosthesis procedure, when milling the cup, the aesculap 3 ti machine failed and it was no longer possible to apply torque to the machine. Then the surgeon had to spend a lot of time and effort to get another machine out of the surgery room tool, which placed additional demands on the sterilization process. There was no harm to the patient, but the surgery and thus the time of anaesthesia was extended. An additional medical intervention was necessary. Additional information was not provided nor available was not available. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameACCULAN 3TI DRILL AND REAMER
Type of DevicePOWER 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
nadine schweikart
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10159185
MDR Text Key195293858
Report Number9610612-2020-00213
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGA672
Device Catalogue NumberGA672
Device Lot Number51853502
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/16/2020 Patient Sequence Number: 1
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