MAUDE Adverse Event Report: AESCULAP AG CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM; CRANIAL FIXATION

Model Number	FM921T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
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 that there was an issue with fm921t - cranioplate 1.5 scr.Mag.Cross l:4mm.According to the complainant, during the procedure, nail breakage and burr occurred.The operation time was prolonged as a result.The complaint device was returned to the manufacturer for evaluation.There was significant surgery delay.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: we made a microscopic investigation of all nine screws.We made a microscopic investigation of all nine screws.The rest of the thread of screw a is in a good condition.The fracture surface of screw a shows the typical signs of a screw that was torn off by excessive torque.The phillips head of screw a shows significant wear and deformation.The rest of the thread of screw b shows little damages.The fracture surface of screw b shows the typical signs of a screw that was torn off by excessive torque.The phillips head of screw b shows significant wear and deformation.The rest of the thread of screw c is in a good condition.The fracture surface of screw c shows the typical signs of a screw that was torn off by excessive torque.The phillips head of screw c shows significant wear and deformation.The rest of the thread of screw d is in a good condition.The fracture surface of screw d shows the typical signs of a screw that was torn off by excessive torque.The phillips head of screw d shows only minor wear.The rest of the thread of screw e shows minor deformation.The tip of screw e is in a good condition.The phillips head of screw e shows only minor deformation.The rest of the thread of screw f is minor deformed.The tip of screw f is in a good condition.The phillips head of screw f shows significant wear deformation.The rest of the thread of screw g is damaged and deformed.The fracture surface of screw g shows the typical signs of a screw that was torn off by excessive torque.The phillips head of screw g shows wear and deformation.The rest of the thread of screw h is in a good condition.The fracture surface of screw h shows the typical signs of a screw that was torn off by excessivetorque.The phillips head of screw h shows only minor wear and deformation.The rest of the thread of screw i is slightly deformed.The fracture surface of screw i shows the typical signs of a screw that was torn off by excessive torque.The phillips head of screw i shows minor wear.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 5 similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 5(10) probability of occurrence7(10)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: there is no indication for a material-, manufacturing- or design-related failure.Without further knowledge about the circumstances we suspect that the surgeon made some handling errors during implantation.Based upon the investigations results a capa is not necessary.

• Brand Name: CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM
• Common Device Name: CRANIAL FIXATION
• 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: 12920812
• Report Number: 9610612-2021-00755
• Device Sequence Number: 5111882
• Product Code: JEY
• UDI-Device Identifier: 04038653463671
• UDI-Public: 4038653463671
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060492
• 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): 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FM921T
• Device Catalogue Number: FM921T
• Device Lot Number: 52584299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2020
• 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
• Patient Sex: Unknown