MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X45MM CANULATED; SPINE SURGERY

Model Number SY644TS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported that there was an issue with the product sy644ts - ennovate polyax.Screw 7.5x45mm canulated.According to the complaint description, the set screw popped out several times during the final fixation with a torque wrench.The same issue occured with the replaced screw, after several attempts the screw could finally be fixed.This malfunction prolonged the surgery.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: implant received with damaged threads on both sides inside the body.Aesculap ag made a visual inspection of the complained implant.Except the damages of the threads we found the hexagon slightly deformed.Device history record: the device quality and manufacturing history records (dhr) 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 no other similar complaints within this batch.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: -malfunction (report not later than 30 days).The assessment for the reportability of this malfunction was based on the applicable risk analysis.Conclusion / preventive measures: on the basis of the available information as well as the investigation results a clear root cause / conclusion of the reported failure cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.It is important to ensure that the set crew is not cross-threaded.Based upon the investigations results a capa is not necessary.

• Brand Name: ENNOVATE POLYAX.SCREW 7.5X45MM 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: 18439087
• MDR Text Key: 331907458
• Report Number: 9610612-2023-00277
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY644TS
• Device Catalogue Number: SY644TS
• Device Lot Number: 52790627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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