MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X60MM CANULATED; ENNOVATE IMPLANTS

Model Number SY647TS

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Implant Pain (4561)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

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 sy647ts ennovate polyax.Screw 7.5x60mm canulated.According to the complaint description, the patient complained of pain, revision done.When revision was done, it was noted that (x4) caps were loose.Whilst removing the screws, the head of screw were loose from screw shaft thread.A revision surgery was necessary.Additional information was not provided nor available was not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: we made a visual inspection of the screw.Here we found the gap between the body and the head.This is a sure hint that the parts of the screw detached during unscrewing.In the next step we disassembled the screw completely.This was possible without any problems.The investigation of the fine thread showed no defects or deformation.Batch 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 no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: the possible dismantling of the screw during a revision (head/body) is not a malfunction.The instructions for use (ifu) points out the possibility of a dismantling during revision and the necessary actions to remove the thread body.Because the screw is mounted counterclockwise, the described effect only occurs during revisions.Per ifu: if the screw head comes loose during revision of the larger polyaxial screws (7.5 mm or larger), remove the remaining screw component with the set screw driver.Conclusion and root cause: due to the current deviation, and according to explanation above, the root cause of the problem is most probably design-related.Design-related because the screw is composed of 2 components, but there is no design failure.A capa is not necessary.

• Brand Name: ENNOVATE POLYAX.SCREW 7.5X60MM CANULATED
• Type of Device: ENNOVATE IMPLANTS
• 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: 11447264
• MDR Text Key: 247529695
• Report Number: 9610612-2021-00211
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04046964987465
• UDI-Public: 4046964987465
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY647TS
• Device Catalogue Number: SY647TS
• Device Lot Number: 52443420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention