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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) was made and of the threaded pin (np586r). Here we found visible helix traces were found. Additionally a visible damaged tip was detected and grooves in the borehole was discovered. The boreholes were examined with a control gauge and it was determined that they are not complying with our specifications. Batch history review: ns334r: the device quality and manufacturing history records have been checked for the lot number (4508169307) and found to be according to the specification, valid at the time of production. Three similar incidents have been filed with a product from the batch. Conclusion and root cause: the root cause of the problem is most probably manufacturing related. Rationale: investigations lead to the assumption that the grooves in the boreholes were caused by a failure during manufacturing. The quirks and visible helix traces may have been caused by the by the grooves, a 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. Due to a material throw-up and grooves in the borehole, there is the possibility that the pin and the inner surface of the hole could have been cold welded. 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: 9610612-2019-00074.
 
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 Key8370999
MDR Text Key139339671
Report Number9610612-2019-00066
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 Manufactured01/25/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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