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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS ENDURO TIBIA HEMI-WEDGE T3 4MM RM/LL KNEE ENDOPROSTHESES

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AESCULAP AG AS ENDURO TIBIA HEMI-WEDGE T3 4MM RM/LL KNEE ENDOPROSTHESES Back to Search Results
Model Number NB065Z
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation results: the complained device and packaging was examined visually and microscopically. The sealed seam of the inner and outer sterile packaging was penetrated/damaged by the implant from inside out. The visual inspection of the sealed seams including a peel force test revealed no deviation from the desired value. There are no indications that the packages were not sealed in a proper way. During the investigation tiniest damages of the packages could be determined. These damages lead to a loss of the vacuum inside the packaging. As a consequence of this, the freedom of movement of the device in the packaging is widening, whereby high forces act on the sealed seams and lead finally to the breakthrough. The packaging processes in the responsible production department are validated. The packages itself will be reviewed by 100 per cent visual inspection within the production process. Therefore it can be excluded that the packages have left the aag in such a damaged condition. " the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specification valid at the time of production. No similar incidents have been filed with products from this batch. Based on the information available as well as a result of our investigation the root cause of the failure is most probably transport related. Probably the damages of the inner and outer sterile packaging was caused due to several shipping cycles to several hospitals.
 
Event Description
It was reported that there was an issue with the packaging of the product as enduro tibia hemi-wedge t3 4 mm rm/ll. During an enduro surgery, the packaging of both implants was damaged and therefore no longer sterile. One time the primary packaging was affected, the other time the secondary packaging. There was no patient harm. There was an slight delay in surgery. Additional information was not provided. The adverse event/malfunction is filed under aag reference (b)(4). Associated medwatch-reports: (b)(4)_9610612-2019-00652.
 
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Brand NameAS ENDURO TIBIA HEMI-WEDGE T3 4MM RM/LL
Type of DeviceKNEE ENDOPROSTHESES
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 Key9119987
MDR Text Key160322591
Report Number9610612-2019-00651
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K101815
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
Report Date 09/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNB065Z
Device Catalogue NumberNB065Z
Device Lot Number52026629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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