MAUDE Adverse Event Report: AESCULAP AG S4 SET SCREW NEW VERSION; SPINE SURGERY

Model Number SW790T

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

If additional information becomes available a follow up report will be submitted.

Event Description

It was reported that there was an issue with s4 set screw.According to the customer complaint."l4/l5 fixation using s4 and sri(spondylolisthesis reduction instrument).When inserting set screws into the screws in l5, the rod was slightly elevated in l4 screws and there was a slight gap between the rod and the screws.In right l4, the surgeon attempted to screw in the set screw using a set screw starter, but the set screw rotated idly, so he removed the set screw in question to replace it with a brand new one.The surgeon used two set screws in the left screw of l4, but both rotated idly in the left side, too.Finally, for the right l4 screw, the surgeon managed to fix the second set screw, and it was successful.For the left, the surgeon attempted carefully to fix one of the two failed set screws, and he succeeded in finally tightening the set screw.There was no need for replacement of pedicle screws.It is unknown exactly how long the surgical procedure was delayed.There was no patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00949 ((b)(4) sw790t).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2019-00949 ((b)(4),sw790t).General information: intra operative incident.The screw arrived in decontaminated condition.Consequences for the patient: according to the available information there were no negative consequences for the patient.Investigation: we made a visual inspection of the screw.In the first step we investigated the hexagon.The hexagon exhibit no signs of wear or damages, which were signs of a not correct applied hex- key.In the next step we investigated the bottom of the screw.Here we found the typically circular wear of a not proper tightened screw, respectively a screw who was tightened over a not correct placed rod.A sample of the bottom and the wear marks of a correct inserted and tightened set screw is shown.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 a not correct (tilted) applied rod.A material failure 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: S4 SET SCREW NEW VERSION
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9702351
• MDR Text Key: 179416244
• Report Number: 9610612-2019-00950
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K032219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW790T
• Device Catalogue Number: SW790T
• Device Lot Number: 52457096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention