MAUDE Adverse Event Report: AESCULAP AG ENNOVATE SET SCREW STERILE; IMPLANTS POSTERIOR STABILISATI

Model Number SY001TS

Device Problems Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with ennovate set screw.It was reported that there was a slight screw misalignment and screw loosening 10 month postoperative.Primary surgery: (b)(6) 2019.Revision surgery: (b)(6) 2020.Two screws are affected with different batch numbers.A revision surgery was necessary.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00015 ((b)(4) + sy001t).

Manufacturer Narrative

Associated medwatches: 9610612-2020-00015 ((b)(4) sy001ts); 9610612-2020-00093 ((b)(4) sy001ts).General information: the implant arrived in decontaminated condition.Consequences for the patient: post- operative medical intervention was necessary.Investigation: at first we made a visual inspection of the received two screws, afterwards called "a" and "b".At the top / interface of screw "a" we noticed only slight and normal wear marks.The body exhibits no damages like bended or sheared off threads.In the next step we investigated the bottom of screw "a".Here we noticed the sickle shaped impression which is a hint that the screw was tightened over a correct applied rod.In the next step we investigated the top / interface of screw "b".Here we noticed slight bending and wear marks, but there are still in a normal range.The body and thread of screw "b" exhibit no damages like bended or sheared off threads.After that we investigated the bottom of screw "b".Also here we found the sickle shaped impression, which is a hint that the screw was tightened over a correct applied rod.For comparison a sample of an other explanted screw is shown, which was correct tightened.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 sickle shaped impression on the bottom of the screws is a sure hint for tightening with correct applied rod.We assume, that the screws were not tightened with the correct torque.The ifu points out to ensure the tightening with the right torque.A material defect or a manufacturing error can be excluded.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: ENNOVATE SET SCREW STERILE
• Type of Device: IMPLANTS POSTERIOR STABILISATI
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9871821
• MDR Text Key: 184719749
• Report Number: 9610612-2020-00093
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• 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: 52503219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention