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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ACCULAN 3TI REAMER ATTACHM.HUDSON/ZIMMER LARGE BONE POWER SYSTEMS

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AESCULAP AG ACCULAN 3TI REAMER ATTACHM.HUDSON/ZIMMER LARGE BONE POWER SYSTEMS Back to Search Results
Model Number GB656R
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/18/2019
Event Type  Injury  
Manufacturer Narrative
Investigation results: we did receive the device in decontaminated condition for investigation. The device has been provided disassembled. The screw which is screwed in into the collet has broken-off. The remaining part can be seen inside the case. The investigation has been carried-out by the aesculap technical service (ats). The device gb656r with the serial number (b)(4) was distributed in february 2019. According to our database, no repair/maintenance took place in the past. Optically, the device is in a good condition. The screw with the article number gb656205 has broken-off. Therefore the tool mount has fallen apart. There are several reasons for the breaking of the screw: it is possible that a too high tightening torque was applied when screwing in the screw (manufacturing related). It is possible that the screw was damaged due to a fall or impact damage (usage related). However, no clear signs of damages can be found on the device.
 
Event Description
It was reported that there was an issue with a acculan 3ti reamer. When milling the acetabulum, the milling cutter broke apart. Additional measures were taken as a result of the event. Additional antibiotics were necessary according to the current knowledge. Further queries are still pending. Additional information was not provided up to now. The adverse event is filed under aag reference (b)(4).
 
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Brand NameACCULAN 3TI REAMER ATTACHM.HUDSON/ZIMMER
Type of DeviceLARGE BONE 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
kerstin rothweiler
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key8965718
MDR Text Key156764970
Report Number9610612-2019-00602
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 distributor,foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGB656R
Device Catalogue NumberGB656R
Device Lot Number52484801
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2019
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: 09/05/2019 Patient Sequence Number: 1
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