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

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).

• Brand Name: ENNOVATE TRANSCONNECTOR 45-50MM STERILE
• Type of Device: SPINE 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 Key: 9511267
• MDR Text Key: 179424150
• Report Number: 9610612-2019-00980
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SX949TS
• Device Catalogue Number: SX949TS
• Device Lot Number: 52499644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1