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

Model Number	SY647TS
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information investigation results will be provided in a supplemental report.
Event or Problem 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).
Additional 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
• Common Device Name: 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
• Report Number: 9610612-2021-00211
• Device Sequence Number: 3853078
• Product Code: NKB
• UDI-Device Identifier: 04046964987465
• UDI-Public: 4046964987465
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K180433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown