MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SET SCREW STERILE; SPINE SURGERY

Model Number SY001TS

Device Problem Unintended Movement (3026)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

General information: the implant arrived in a decontaminated status.Failure description: the implant exhibit no outwardly defects.Investigation: used test- and analysis- equipment: microscope "keyence- vhx 5000 " eq.-nr.2000024840 at first we made a visual inspection of the received screw.At the top / interface of the key we noticed only slight and normal wear mark.The thread of the screw exhibit no damages or bending.In the next step we investigated the bottom of the screw.The star shaped stripes on the bottom of the screw are hints for a moving rod during the backing out of the screw.The missing of the sickle shaped wear on the bottom is a sure hint for tightening the screw / rod with too less torque.For comparison the picture underside of a correct tightened set screw with sickle shaped wear.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: the wear shapes on the bottom of the screw are a sure hint for tightening with too less torque or a not correct (tilted) applied rod.A material failure or a manufacturing error can be excluded.Corrective action: according to sop (b)(4) (corrective action & preventive action) a capa is not necessary.

Event Description

It was reported that there was an issue with ennovate set screw.The operation and implantation was originally performed in november.The patient then came in for a check up and was complaining of pain.The revision surgery was scheduled and performed.The set screw was just lying on top of the rod and did not need any instrumentation to remove it from the construct apart from some tweezers.This was replaced by a new set screw and the construct is now fixed.A revision surgery was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event is filed under (b)(4).

• Brand Name: ENNOVATE SET SCREW 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: 9770285
• MDR Text Key: 182299669
• Report Number: 9610612-2020-00012
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY001TS
• Device Catalogue Number: SY001TS
• Device Lot Number: 52557403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2019
• 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
• Patient Outcome(s): Required Intervention