MAUDE Adverse Event Report: AESCULAP AG CRANIOPLATE 1.5 KIT 4MM CROS.BURR.COVER; CRANIAL FIXATION

Model Number FM992T

Device Problem Component Missing (2306)

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

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product fm992t - cranioplate 1.5 kit 4mm cros.Burr.Cover.According to the complaint description, a part was found to be missing from the kit package once the inner part was opened.This occurred during skull fixation, postoperatively.The device was replaced immediately.There was a surgical delay.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Device history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.Currently there are no further complaints with this lot and error pattern at hand.Since we do not have a sample to examine and the cause of the allegedly missing part cannot be traced, the risk analysis cannot be applied in this case.Conclusion and 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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: CRANIOPLATE 1.5 KIT 4MM CROS.BURR.COVER
• 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: 17438636
• MDR Text Key: 320243739
• Report Number: 9610612-2023-00192
• Device Sequence Number: 1
• Product Code: JEY
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM992T
• Device Catalogue Number: FM992T
• Device Lot Number: 52801761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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