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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG HANDLE THA F/LATERAL APPROACH OFFSET LT.; HIP ENDOPROSTHETICS
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AESCULAP AG HANDLE THA F/LATERAL APPROACH OFFSET LT.; HIP ENDOPROSTHETICS Back to Search Results
Model Number NT004R
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/02/2020
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 handle tha f/lateral approach.The handle was difficult to lock and it was attempted several times.With the profiler handle being unlocked, staff was able to hold the profiler while grasping the knob by hand and pulled it out with pliers.After that, the implant was successfully inserted and the surgery was completed successfully.The surgical delay due to this handle malfunction was about 10 minutes.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).Associated medwatch report: these case (b)(4) is related to (b)(4).(9610612-2020-00223).
 
Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.
 
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Brand Name
HANDLE THA F/LATERAL APPROACH OFFSET LT.
Type of Device
HIP ENDOPROSTHETICS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key10283035
MDR Text Key202559142
Report Number9610612-2020-00307
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNT004R
Device Catalogue NumberNT004R
Device Lot Number51939080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2020
Date Manufacturer Received08/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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