MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X50MM CANULATED; SPINE SURGERY

Model Number SY635TS

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that there was an issue with sy635ts - ennovate polyax.Screw 6.5x50mm canulated.According to the complaint description, the locking set screw did not fully seat into the screw head and could not be finally tightened.Therefore, the surgeon decided to replace the set screw.After removing it, he found that the set screw was fine, but that the screw head thread had been destroyed.Thus, the surgeon replaced the entire screw.The operating time was extended by 1 hour.Damage to tulip inner screw threads was noted.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference 400585276 (xc 100032288).Associated medwatch reports: sy635ts (9610612-2023-00019) - 400585274, sy635ts (9610612-2023-00020) - 400585275, sy635ts (9610612-2023-00021) - 400585276, sy634ts (9610612-2023-00022) - 400585277.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information/ correction: h6 - codes updated.Investigation results: as of the date of this report the complaint product was not provided for investigation.No investigation method could be applied, because: there are no products available, therefore an investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.The lot of the product is unknown, a dhr check therefore is not possible.Explanation and rationale: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawnroot cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

Event Description

The adverse event is filed under aag reference: (b)(4).Associated medwatch reports: sy635ts (9610612-2023-00019) - 400585274.Sy635ts (9610612-2023-00020) - 400585275.Sy635ts (9610612-2023-00021) - 400585276.Sy634ts (9610612-2023-00022) - 400585277.

• Brand Name: ENNOVATE POLYAX.SCREW 6.5X50MM CANULATED
• 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: 16240658
• MDR Text Key: 308090001
• Report Number: 9610612-2023-00021
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY635TS
• Device Catalogue Number: SY635TS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention