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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG IQ TIBIA/DISTAL FEMUR CUTTING GUIDE INSTRUMENTS FOR KNEE ENDOPROST

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AESCULAP AG IQ TIBIA/DISTAL FEMUR CUTTING GUIDE INSTRUMENTS FOR KNEE ENDOPROST Back to Search Results
Model Number NS334R
Device Problems Mechanical Problem (1384); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation: a visual inspection of the femur cutting guide (ns334r) threaded pin (np583r) was made. Visible helix traces and visible damaged tips were detected. Also grooves in the borehole was found. Examination of the boreholes was made with a control gauge and it was determined that they and not complying with the initial manufacturing status. The boreholes no longer have the initial diameter through material throw-up and using traces. Batch history review: ns334r: the device quality and manufacturing history records have been checked for the lot number (4507758957) and found to be according to the specification, valid at the time of production. One similar incidents has been filed with a product from the batch (4507758957). Conclusion and root cause: the root cause of the problem is most probably usage related. Rationale: investigations lead to the assumption that the grooves in the boreholes, quicks and grooves were caused by a usage error due to a material throw-up of the pin. The boreholes no longer have the initial diameter through material throw-up and using traces. The quirks and visible helix traces may have been caused by the material throw-up and the additional movement through using the pin. Particles or forces applied during corrections while navigating may have led to a material throw-up. There is a possibility for pre-damage or similar due to previous surgeries. If the instruments are in such poor condition they should no longer be used. Due to a material throw-up and grooves in the boreholes, there is the possibility that the pin and the inner surface of the hole could have been cold welded. The cold welded is the cause for the deformed shaft. We cannot determine the exact cause for the visible damaged tip. According to the instructions for use (ifu) the following points and warnings much be observed: excerpt from ifu: prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. Do not use the product if it is damaged or defective. Set aside the product if it is damaged replace any damaged components immediately with original spare parts. A capa was initiated. Associated medwatch: 9610612-2019-00081.
 
Event Description
It was reported intraoperatively the pins stuck in cutting guide. During a surgical procedure it was reported the threaded pin got stuck in the cutting guide. Per the information available, there was no negative consequence to the patient and no reported delay in the procedure. Additional information was requested regarding patient outcome and any additional medical intervention required.
 
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Brand NameIQ TIBIA/DISTAL FEMUR CUTTING GUIDE
Type of DeviceINSTRUMENTS FOR KNEE ENDOPROST
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key8372244
MDR Text Key137731024
Report Number9610612-2019-00072
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 02/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNS334R
Device Catalogue NumberNS334R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date02/06/2019
Event Location No Information
Date Manufacturer Received02/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2016
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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