MAUDE Adverse Event Report: AESCULAP AG S4 ELEMENT POLYAXIAL SCREW 6.0X55MM; IMPLANTS POSTERIOR STABILISATION

Model Number ST266T

Device Problem Unintended System Motion (1430)

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

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a s4 element polyaxial screw 6.0x55mm (part # st266t) was used during a procedure performed on an unknown date.According to the complainant, the device disintegrated during surgery.During the operation, surgeon wanted to turn the head of the screw so that it was inserted into the patient and the screw "disintegrated", the inner sealing ring was loosened.The patient was not damaged, the surgeon had to remove the screw and use a new one.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference (b)(4).Associated medwatch reports: 9610612-2021-00756 - 400526775, 9610612-2021-00758 - 400527068.

Manufacturer Narrative

Investigation results: visual investigation: investigation was carried out visually and microscopically.On the flanks of the body are two slots for "clamping" the inlay.For this the inlay is equipped with two catches snaps to snap into the slots.At the edge of one slot a minor wear is visible what is a sure evidence that the inlay was correct mounted before delivering.At the other edge a burr is visible.This is a hint, that the insert became loose during applying excessive force on it.The product left aesculap ag in a condition according to specification.A material defect or a manufacturing error can be excluded.Without further knowledge about the circumstances we assume, that maybe excessive force during handling lead to the deformation of the catch- noses of the insert and the loosening of this.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 risk assessment revealed that the overall risk level (severity 4(10) x probability of occurrence 5(10)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results there is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: S4 ELEMENT POLYAXIAL SCREW 6.0X55MM
• Type of Device: IMPLANTS POSTERIOR STABILISATION
• 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: 12920847
• MDR Text Key: 281667128
• Report Number: 9610612-2021-00758
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04046963739294
• UDI-Public: 4046963739294
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K090657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST266T
• Device Catalogue Number: ST266T
• Device Lot Number: 52621830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2021
• 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