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

Model Number SY001TS

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/18/2019

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 the product ennovate set screw.Intra-operative loosening of set screw.During a posterior lumbar interbody fusion( plif) procedure to l4/l5/s1, the surgeon tightened set screws to tighten the rod.However, he was unable to tighten the set screw in the screws placed in s1.According to the surgeon, the set screw loosened out of the screw head.Intra-operative remedial action: the surgeon removed the set screws, removed the rod, and replaced the screw.Then the physician set the rod again to tighten the set screws.Additional intervention was required.The adverse event is filed under aag reference (b)(4).Associated medwatch: 9610612-2019-00835.

Manufacturer Narrative

Associated medwatch report: 9610612-2019-00835 (b)(4).General information: intra operative incident.Consequences for the patient: surgery delay was longer than 15 minutes.Failure description: we received one set screw sy001ts and one pedicle screw sy643ts.Investigation: used test- and analysis- equipment: microscope "keyence- vhx 5000 " eq.-nr.2000024840, digital-camera "panasonic dmc tz8." first we made a visual inspection of the set screw.The interface on the top is in a proper condition (fig.2) but the bottom exhibit circular wear, which is a hint for pushing down the rod during screwing in the set screw.The thread of the set screw is damaged at several points.In the next step we investigated the pedicle screw.Here we found the thread in the body in a proper condition at one side and damaged at the other side shows the pedicle screw with the set screw partially screwed in.The body is not spread off.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 damage of the thread could have two root causes, both usage related: cross threading of the set screw, tightening the set screw without counter torque.The ifu figures out to avoid both of this.The expansion of the screw head mentioned in the complaint description is a clear hint for tightening without counter torque.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: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9432268
• MDR Text Key: 169728600
• Report Number: 9610612-2019-00834
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 52498133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention