MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD DISPOSABLE ADULT SKULL PINS (STEEL); ACCESSORIES

Catalog Number	A1083
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Skull Fracture (2077)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that when the mayfield disposable adult skull pins (a1083) was attached to the patient, the bone was broken through (tabula interna); the thorn/pin was too sharp.Additional information received indicates that during positioning of the patient and fixation of the skull clamp, the pin broke through the skull/fracture.Patient is currently reported as "ok", but has the fracture.There was delay of 20 minutes reported.Further additional information was received stating that "indication of surgery was op: cavernom at pinealis-region.".
Additional Manufacturer Narrative
Mayfield disposable adult skull pins (a1083) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - failure analysis cannot be completed, as the skull pin was discarded by the customer.The customer provided x-ray images which appear to show a skull fracture.However, without the return of the skull pin it cannot be confirmed if this was due to a deficiency with the skull pin.Root cause - the definite root cause cannot be identified as the device was not returned.Based on the reported complaint, probable root cause is improper placement of the skull clamp and pins or excessive force applied.This will be monitored and trended going forward.

• Brand Name: MAYFIELD DISPOSABLE ADULT SKULL PINS (STEEL)
• Common Device Name: ACCESSORIES
• 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: 18107640
• Report Number: 3004608878-2023-00203
• Device Sequence Number: 12262936
• Product Code: HBL
• UDI-Device Identifier: 10381780025788
• UDI-Public: 10381780025788
• Combination Product (Y/N): N
• PMA/510(K) Number: K932860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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 Catalogue Number: A1083
• Device Lot Number: 6874894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 01/12/2024
• Date Device Manufactured: 12/14/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Unknown