MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X50MM CANULATED; SPINE SURGERY

Model Number SY645TS

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2019

Event Type  malfunction  

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 polyaxial screw.When tightening the set screw, the set screw moved inside the screw head.It was noted that the set screw had been positioned without problem.The surgeon ruled out cross threading and suspected widening of the screw head.The screw was replaced and the surgical procedure went well thereafter.This event/malfunction prolonged the surgery for approximately 15 minutes.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event/malfunction is filed under (b)(4).Associated medwatch-reports: 9610612-2019-00925 ((b)(4) sy001ts).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2019-00925 (400457827 sy001ts).General information: intra operative incident.The implants arrived in decontaminated condition.Consequences for the patient: surgery delay was longer than 15 minutes.Failure description: three set screws sy001ts arrived in common with a pedicle screw sy645ts investigation used test- and analysis- equipment: · microscope "keyence- vhx 5000 " eq.-nr.2000024840; · digital-camera "panasonic dmc tz8".In the first step we investigated the three set screws.Screw "a" exhibit slight wear at the torx and a partially damaged thread.At the bottom this screw exhibit strange wear marks.Screw "b" shows a proper torx and a proper thread.At the bottom this screw exhibit the sickle shaped dent of a proper inserted and tightened screw.At last, screw "c" exhibit no kind of wear, neither at the torx, nor at the thread or the bottom.In the next step we investigated the pedicle screw.Here we noticed some heavily damages at the body- thread and wear on the inlay.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 strange marks at the bottom of screw "a" are normally known from screws which were implanted and not correct tightened, so that the rod was able to move back and forth while the set screw backs out.The only partially damage of the thread is unusual and no sign of a typically cross threading during the implantation handling.The damages on the thread of the pedicle screw are not typically for cross threading too.Parts of the thread are bent downwards.Such a damage is normally not possible during insertion of the set screw.Without further knowledge about the circumstances we assume a handling with instruments which are not suitable for the ennovate system or the possibility that the complained screws maybe are explants.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 POLYAX.SCREW 7.5X50MM CANULATED
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9604866
• MDR Text Key: 179490547
• Report Number: 9610612-2019-00924
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY645TS
• Device Catalogue Number: SY645TS
• Device Lot Number: 52560140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1