MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X40MM CANULATED; SPINE SURGERY

Model Number SY633TS

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2023

Event Type  malfunction  

Event Description

It was reported that there was an issue with sy633ts - ennovate polyax.Screw 6.5x40mm canulated.According to the complaint description, after inserting the screws into l4 and l5 of the lumbar vertebrae, the screws and rods were attached using a rod pusher.However, the screws came out on only one side, so they were replaced with 7.5 mm products.There was temporary impairment; possibility of screws coming loose.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2023-00219 ((b)(4)).

Manufacturer Narrative

Investigation: up to now there is no sample available.Therefore, there is no investigation possible.Device history review: 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 currently no further complaints with this lot and error pattern at hand.The current failure rate is within the risk analysis and therefore acceptable according to procedures; severity was 4(5) and probability 2(5).Conclusion and preventive measures: based upon the investigation results, a clear root cause cannot be determined.Multiple quality checks are performed on the product, and a material or manufacturing defect is unlikely.In the future, if the product is returned, another investigation will be performed at that time.Based upon the investigation results, a capa is not necessary.

• Brand Name: ENNOVATE POLYAX.SCREW 6.5X40MM 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17857640
• MDR Text Key: 324772751
• Report Number: 9610612-2023-00217
• 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: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY633TS
• Device Catalogue Number: SY633TS
• Device Lot Number: 52809533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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