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

Model Number	ST266T
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9610612-2021-00758
• Device Sequence Number: 5111889
• Product Code: NKB
• UDI-Device Identifier: 04046963739294
• UDI-Public: 4046963739294
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K090657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown