MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 7.5X80MM SOLID; ENNOVATE IMPLANTS

Model Number SY149TS

Device Problem Device Damaged by Another Device (2915)

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

Event Date 04/06/2021

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 sy149ts - ennovate polyax.Screw 7.5x80mm solid.According to the complaint description, the breakage of the ennovate screw was noticed when, after several attempts, they failed to apply the blockade.There was no described patient harm.Additional information was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Updated information: updated patient harm to "additional medical intervention".B1: report type.B2: outcomes attribute to adverse event.B5: update.D9: device returned to manufacturer.Visual investigation: investigation was carried out visually and microscopically.A gap was found between the bottom of the head and the low side of the insert.The insert is loose.The thread of the head and the hexagon shows heavy wear and tear and deformation signs.It is not 100% clear whether the damage to the screw (loosened inlay) was caused by manufacturing or by usage error (levering in the hexagon during insertion).Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of the risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

Event Description

Update: an additional medical intervention was required.

• Brand Name: ENNOVATE POLYAX.SCREW 7.5X80MM SOLID
• 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: 11855984
• MDR Text Key: 251740836
• Report Number: 9610612-2021-00418
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY149TS
• Device Catalogue Number: SY149TS
• Device Lot Number: 52468721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2018
• 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
• Patient Outcome(s): Required Intervention