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

Model Number A2020

Device Problem Material Fragmentation (1261)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/27/2022

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the tip on the mayfield radiolucent skull pins (a2020) splintered and broke off in the patient's scalp, and the surgeon needed to explore the scalp to find the lost piece.The incident occurred when the pins were being removed at the end of craniotomy procedure; this caused quite a bit of bleeding which ended up making the case go longer for 20 minutes.

Manufacturer Narrative

The mayfield radiolucent skull pins (a2020) was returned for evaluation: failure analysis - complaint confirmed via inspection of the returned skull pin.The tip of the pin was broken and part of the pin was missing.Root cause - probable root cause includes damage to the pin from mishandling (such as dropping the skull pin) or from improper seating of the skull pin in the mayfield skull clamp.

• Brand Name: MAYFIELD RADIOLUCENT SKULL PINS
• Type of Device: RADIOLUCENT PRODUCT 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: 14776837
• MDR Text Key: 294527640
• Report Number: 3004608878-2022-00129
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A2020
• Device Catalogue Number: A2020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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