MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD RADIOLUCENT SKULL PINS; N/A

Catalog Number A2020

Device Problem Fracture (1260)

Patient Problem Skull Fracture (2077)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

The mayfield radiolucent skull pins (a2020) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned a2020 skull pin found that a large shard of the pin had fractured off.A2020 skull pin fracture can result from excessive bending and shear load on the skull pin.No damage or incident marks were noted on the plastic pin base.Root cause - the complaint is confirmed via inspection of the unit.Probable root cause includes improper or suboptimal seating and placement of the pins resulting in an excessive shear force on the pin.Additionally, the radiolucent pins are fragile and susceptible to damage from rough handling such as dropping.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

A facility reported that during a craniotomy procedure, the mayfield radiolucent skull pins (a2020) fractured in the patient's head.Patient was pinned and once under pressure they saw patient bleeding and noticed piece was broken and in the pin site of the patient's scalp.The mayfield device was removed, revealing that the right frontal pin had splintered, causing a very small laceration on the pin site.The site was irrigated and closed with a single 4-0 vicryl horizontal mattress.The patient is currently healing.There was no surgical delay.

• Brand Name: MAYFIELD RADIOLUCENT SKULL PINS
• Type of Device: 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: 18383777
• MDR Text Key: 331294780
• Report Number: 3004608878-2023-00236
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780025818
• UDI-Public: 10381780025818
• Combination Product (y/n): N
• PMA/PMN Number: K071458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A2020
• Device Lot Number: 7253088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female