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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AS ENDURO TIBIA HEMI-WEDGE T2 4MM RM/LL; KNEE ENDOPROSTHESES
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AESCULAP AG AS ENDURO TIBIA HEMI-WEDGE T2 4MM RM/LL; KNEE ENDOPROSTHESES Back to Search Results
Model Number NB045Z
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2020
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 a enduro tibia hemi-wedge.According to the complaint description one of the tibia wedges was already open when customer wanted to use it.There was no case delay or impact to the patient.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).
 
Manufacturer Narrative
In the light of the small amount of information received and due to the circumstance that we did not receive the complained device/packaging for investigation, it is not possible to determine a root cause for the mentioned failure.According the 8d report no capa is necessary.
 
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Brand Name
AS ENDURO TIBIA HEMI-WEDGE T2 4MM RM/LL
Type of Device
KNEE ENDOPROSTHESES
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key10581406
MDR Text Key208407937
Report Number9610612-2020-00586
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K101815
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2024
Device Model NumberNB045Z
Device Catalogue NumberNB045Z
Device Lot Number52041602
Was Device Available for Evaluation? No
Date Manufacturer Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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