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

Model Number	FM921T
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: visual investigation: investigation was carried out visually and microscopically.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 fractured during wrong (tilted) applying.The phillips head of screw a shows only minor wear and is in a good condition.The whole thread (flanks) of screw b is deformed.The fracture surface of screw b shows the typical signs of a screw that was fractured during wrong (tilted) applying.The phillips head of screw b shows only minor wear and is in a good condition.Without further knowledge about the circumstances we suspect that the surgeon made some handling errors during implantation.The ifu points out to consider some points during handling and implantation.The discoloration mentioned in the complaint could not be confirmed by the analysis.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 5(10) x probability of occurrence 7(10)) 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 or Problem Description
It was reported to aesculap ag that a cranioplate 1.5 scr.Mag.Cross l:4mm (part # fm921t) was used during a procedure performed on an unknown date.According to the complainant, during sterilization, the device discolored and broke.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

• 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: 12927133
• Report Number: 9610612-2021-00732
• Device Sequence Number: 17369956
• Product Code: JEY
• UDI-Device Identifier: 04038653463671
• UDI-Public: 4038653463671
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 12/03/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown