MAUDE Adverse Event Report: AESCULAP AG KERRISON BLK COATED 130 UP 180X1MM THIN; MICRO NEUROSURGICAL INSTR. / D

Model Number FK906B

Device Problem Material Fragmentation (1261)

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

Event Date 03/15/2023

Event Type  Injury  

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 fk906b - kerrison blk coated 130 up 180x1mm thin.According to the complaint description, the tip was broken during surgery.Patient harm was unknown.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Additional information: h6 - codes updated investigation: no product available.Therefore an investigation of the product is not possible.Review of batch history records: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Conclusion/preventive measures: unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Based on the investigation results, a capa is not necessary.

Event Description

Update: patient harm changed from unknown to additional medical intervention necessary.The adverse event is filed under aag reference (b)(6).

Manufacturer Narrative

Additional information/ correction: b1 - report type, b2 - outcome of the adverse event, b3 - date of the event added, b5 - patient harm updated, h1 - type of the event, h6 - code added.

Manufacturer Narrative

Additional information: h6 - codes updated.Investigation: no product available.Therefore an investigation of the product is not possible.Review of batch history records: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Conclusion/preventive measures: unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Based on the investigation results, a capa is not necessary.

Manufacturer Narrative

Investigation: this failure mode resulting from this case has been evaluated in another complaint and can therefore be defined as a repeating failure mode.The repeating failure mode was confirmed based on photo documentation.After product return, the investigation was updated.In case of failure of the punches the material and the associated properties (e.G.Hardness) must first be checked.If there are no negative results here, the punch has been used beyond its stability limit and is deforming due to the overload of the material and the associated construction.The instructions for use (ifu) contain information on the overload and on the twisting and lever during use and the lever during the punching process.We have measured the hardness test.The test was carried out with the test device with the ident no.38374.The results were as follows: target value: 420+110 h5/h10.Actual value: 475h5/h10.The results are within specification.Material has been checked according to dhr and also complies within the specification.Furthermore the statistical strength of the bone punches was increased to minimise the deformation of the punches as a defect pattern review of batch history records: 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.The current failure rate is within the risk analysis and therefore acceptable; severity was 3(5) and probability 1(5).Explanation and rationale: the punch (cutting part of wangler) has been used beyond its stability limit and is deforming due to the overload of the material and the associated construction.Conclusion/preventive measures: based on the investigation results, a clear root cause cannot be determined.It is most probably due to handling.Based on the investigation results, a capa is not necessary.

• Brand Name: KERRISON BLK COATED 130 UP 180X1MM THIN
• Type of Device: MICRO NEUROSURGICAL INSTR. / D
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16657984
• MDR Text Key: 312617602
• Report Number: 9610612-2023-00071
• Device Sequence Number: 1
• Product Code: LRY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• 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,Followup,Followup,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FK906B
• Device Catalogue Number: FK906B
• Device Lot Number: 4510777724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention