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

Model Number SY633TS

Device Problem Packaging Problem (3007)

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

This report is submitted due to a product safety case (psc) that was initiated on 13.09.2023.This psc was initiated in order to reduce the current severity 4(5) of the reported malfunction.For the lot 52854868 (83 pieces), an outer packaging with color and written marking for a 7.5 mm long screw was provided during order-related preparation and commissioning procedures, so the outer packaging does not match the product and other markings/labels.The diameter on the label is correct and shows the 6.5 mm.There is a risk that a thread is pre-cut with a 7.5 mm tap and then a 6.5 mm screw is implanted, and on the other hand, there is a risk that if a 6.5 mm screw is implanted instead of a planned 7.5 mm screw.This is at the disadvantage of stability.Within the past five years (01.08.2018-15.09.2023) there was only one complaint for the same error pattern.The root cause is an individual employee error during order-related preparation and commissioning procedures.Corrective actions/ preventive actions: a field safety corrective action (fsca) was initiated on 19.09.2023.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 sy633ts - ennovate polyax.Screw 6.5x40mm canulated.According to the complaint description, the packaging is not corresponding with the product.The colour coding "green" of the size implant 7.5 doesn't correspond to the reference number and description of the product 6.5 screw.Two screws were delivered with the reported defect.There was no described patient harm.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

The packaging of the implant with the color coding green of size 7.5 does not match the reference number and the description of the product 6.5 screw.For the lot 52854868 (83 pieces), an outer packaging with color and written marking for a 7.5 mm long screw was provided during order-related preparation and commissioning procedures, so the outer packaging does not match the product and other markings/labels.The diameter on the label is correct and shows the 6.5 mm.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.The current failure rate is within the risk analysis and therefore acceptable per procedures; severity was 4(5) and probability 2(5).Conclusion and root cause: the root cause is manufacturing related.It was an individual employee error during order-related preparation and commissioning procedures.Corrective actions preventive actions: a field safety corrective action (fsca) was initiated and deviation was created.

• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17873420
• MDR Text Key: 326011374
• Report Number: 9610612-2023-00225
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 10/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• 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: 52854868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2023
• 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