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

Model Number FM921T

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

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 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 the procedure, the screw was broken.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: visual investigation: 331 screws with broken off tip and deformations arrived for investigation.The broken off tips were not enclosed.Investigation was carried out visually and microscopically.All screws show damage.These are pronounced to different degrees on all screws.They are in detail: damaged threads, damaged phillips screw heads, broken screw tips and deformations.The fracture surface of the broken off tips show the typical signs of a screw that was torn off by excessive torque.The phillips heads show significant wear and deformation.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.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 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.

• Brand Name: CRANIOPLATE 1.5 SCR.MAG.CROSS L:4MM
• Type of Device: 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: 12924190
• MDR Text Key: 281845914
• Report Number: 9610612-2021-00765
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 04038653463671
• UDI-Public: 4038653463671
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM921T
• Device Catalogue Number: FM921T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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