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

Model Number SY001TS

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that there was an issue with the product sy001ts - ennovate set screw sterile.According to the complaint description, the connector slipped and the ilium screw was not connected.A revision due to postoperative migration was performed at six (6) months.A revision was necessary.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision.Additional information was not provided nor available.The adverse event is filed under aesculap ag reference no.(b)(4).Associated medwatch-reports: 9610612-2024-00015 (internal aesculap ag ref.No.(b)(4) - sy704ts).9610612-2024-00052 (internal aesculap ag ref.No.(b)(4) - sy904ts).

Manufacturer Narrative

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

Event Description

Update: previously, there were three (3) leading materials.After the investigation completion, it was confirmed that there was only one (1) leading material, sy001ts (internal aesculap ag ref.No.(b)(4)).Associated medwatch-reports: 9610612-2024-00053 (internal aesculap ag ref.No.(b)(4) - sy001ts).Involved components: 9610612-2024-00052 (internal aesculap ag ref.No.(b)(4) - sy904ts).9610612-2024-00015 (internal aesculap ag ref.No.(b)(4) - sy704ts).

Manufacturer Narrative

Additional information: b5 - associated medwatch reports and involved components updated.D10 - involved components.H3 - yes, evaluation.H6 - codes updated.Investigation results: a visual and microscopical investigation of all received implants was made.In the first step, the rod connector sy704ts was investigated ((b)(4)).The hexagons of the two tightening screws show minor deformation, caused by tightening the rod(s).The deformations of the hexagons are in a normal range for used implants.Apart from a few scratch marks caused by implantation and explantation, there is no real damage.The connector is in a flawless technical condition.In the next step the enclosed rod was investigated.Here too was found no real damage other than a few scratches and wear marks.After that a visual inspection of the screw was made.In the first step the hexagon and the thread were investigated.The hexagon exhibits no signs of wear or damages, which would be signs of a not correctly applied hex key, and the thread is in a flawless condition.In the next step the bottom of the screw was examained.Here were found the typical circular wear of a not properly tightened screw, respectively a screw that was tightened over a not correctly placed rod and an elongated impression caused by the rod underneath and the back and forth movements.Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are currently no further complaints with this lot and error pattern at hand.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision.Conclusion/preventive measures: the cause of the problem described was a rod that was not optimally placed in the head of the pedicle screw.The instructions for use (ifu with the internal reference number: (b)(4)) points out: make certain and check that the screw head is at right angles to the rod.Based upon the investigation results, a capa is not required.

• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18932278
• MDR Text Key: 338075741
• Report Number: 9610612-2024-00053
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 52871276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2023
• 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
• Treatment: SY704TS - LOT 52601110; SY904TS - LOT 52851617
• Patient Outcome(s): Required Intervention