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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE TRANSCONNECTOR 45-50MM STERILE SPINE SURGERY

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AESCULAP AG ENNOVATE TRANSCONNECTOR 45-50MM STERILE SPINE SURGERY Back to Search Results
Model Number SX949TS
Device Problem Unintended System Motion (1430)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: the implant arrived in a decontaminated condition. At first sight, the connector exhibited no damages. Visual inspection of the connector showed that one of the clamping rockers was completely out of position (loose). The cause for it was a bent up interface between the tightening screw and the rocker. The rocker arms of the damaged rocker are completely bent up, a catch of the clamping screw is not possible. Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production. There are no further complaints with this lot at hand. Conclusion and root cause: the root cause for the problem is most probably usage related. Rationale: without further knowledge about the circumstances we suspect, that the cross connector was applied not correctly (right- angled) to the rod. With an improper position of the connector a sufficient tightening of the rod is not possible, even with high torque force applied to the screws of the clamping mechanism. The error pattern is a clear hint for a damage (bending up) caused by a too high torque applied the clamp- screw. The instructions for use (ifu) points out to avoid too high torque on the screws. A material defect or a manufacturing error can be excluded. Hints in the ifu (ta-nr. 014887 2018-04 v6 and. -nr. 58042): implant damage due to overtightening the set screw or insufficient fixation due to undertightening the set screw! check the recalibration/maintenance date on the torque wrnch handle maintenance label prior to each use. When tightening or loosening the set screws, make certain that the working end of the torque wrench handle shaft 5 nm is positioned entirely within the socket of the set screws. Apply the torque slowly and without sudden movement until the torque wrench handle release is audibly triggered. Position the rod-to-rod/cross connector correctly. Make certain that the rods are completely inserted into the rod-to-rod/cross connector. Make certain that there is no soft tissue caught in the rod-to-rod/cross connector use a rigid screw driver to loosen the screw connection. Corrective action - according to (b)(4) (corrective action & preventive action) a capa is not necessary.
 
Event Description
It was reported that there was an issue with an ennovate transconnector. According to the complaint description: the surgeon attempted to engage the connector onto the rod and tightened the screw in the connector, but the rod would not be firmly seated in the connector. According to the surgeon, the screw was tightened, however, it did not feel as if the connector was firmly connected to the rod. Because there was no back-up device, procedure was finished without a connector. It was unknown whether there was a surgical delay. The adverse event is filed under aag reference (b)(4).
 
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Brand NameENNOVATE TRANSCONNECTOR 45-50MM STERILE
Type of DeviceSPINE SURGERY
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 Key9511267
MDR Text Key179424150
Report Number9610612-2019-00980
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K180433
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 12/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSX949TS
Device Catalogue NumberSX949TS
Device Lot Number52499644
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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