MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD TITANIUM DISPOSABLE ADULT SKULL PIN; N/A

Model Number	A1120
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that they initially noticed an artifact on patient mri scan, which caused them to check on the patient and the field to determine what the artifact could be.Initial examination showed no possible ideas.The mri technicians used a handheld metal detector over the patient and it detected metal around the head.They then undraped the patient and upon unpinning the patient, they found two different types of mayfield pins used.They stated that when they prepped the room in the morning, they placed the mayfield pins on the mayfield, and both packages of pins they opened were labeled with the "yellow" titanium sticker which indicates the pins are "mr conditional" (safe to be used).Somehow the inappropriate pins and appropriate mayfield pins were packaged together.There was a delay for 20 to 30 minutes as they removed the old mayfield pins, placed the appropriate pins then re-draped the patient and started a new scan.The patient was not harmed and the case proceeded with no issues.
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Mayfield titanium disposable adult skull pin (a1120) was not returned for evaluation; therefore, an evaluation of the device could not be performed.However, investigation using a photograph provided by the customer was performed as follows: device history record (dhr) ¿ the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the customer provided photographs which showed two open packages labeled as a1120 titanium skull pins and a set of four skull pins, three of which appear to be steel, and one appears to be titanium.The titanium skull pins are anodized gold and have an additional ring lathed into the pin body to distinguish from the steel pins.The manufacturing and packaging processes and operations for both the a1120 titanium disposable skull pins and the a1072 steel disposable skull pins were thoroughly reviewed and there was no indication or evidence that an error occurred during the manufacturing operations.Root cause - based on the information available, the most probable cause was an error during the preparation of the skull clamp application that led to steel pins being unknowingly introduced into the case.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: MAYFIELD TITANIUM DISPOSABLE ADULT SKULL PIN
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16827728
• Report Number: 3004608878-2023-00073
• Device Sequence Number: 1842356
• Product Code: HBL
• UDI-Device Identifier: 10381780253624
• UDI-Public: 10381780253624
• Combination Product (Y/N): N
• PMA/510(K) Number: K072208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: A1120
• Device Catalogue Number: A1120
• Device Lot Number: W2107031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/15/2023
• Date Device Manufactured: 07/20/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown