MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL VANTAGE STEREOTACTIC SYSTEM - FIRMFIX; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	1519676
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a tip of a firmfix screw found to be broken after surgery.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.It was reported that a biopsy was performed on quite heavy patient who moved so severely that the tip of an anterior firmfix sheared off and stayed in the tabula of the patient.The biopsy could be completed as expected and there were no injuries to the patient.The root cause has concluded this to be a combination of: 1.The heavy patient moving and not cooperating during the procedure.2.Firmfix was used with the stop screwing mark being passed indicating that the firmfix was tightened with a high torque.The instructions for use provides information when to stop screwing.3.The material batch for the broken firmfix screw was less hard than the previous batches, but it is still within specification of the specified aluminium quality.This is the only site that has reported firmfix breakages.This is a known risk (severity "marginal") and the risk assessment concluded that the risk is within acceptable levels.The severity of having a aluminum tip remaining in the skull bone was discussed with a neurosurgeon not involved in this case.Feedback was that this may cause minor inconvenience for the patient.

• Brand Name: LEKSELL VANTAGE STEREOTACTIC SYSTEM - FIRMFIX
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer (Section G): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 13926225
• Report Number: 9612186-2022-00001
• Device Sequence Number: 4813769
• Product Code: HAW
• UDI-Device Identifier: 07340048304283
• UDI-Public: (01)07340048304283
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K190887
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1519676
• Device Catalogue Number: 1519665
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown