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

Model Number	A2020
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
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
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.
Additional 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
• Common Device Name: 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
• Report Number: 3004608878-2022-00129
• Device Sequence Number: 20066900
• Product Code: HBL
• UDI-Device Identifier: 10381780025818
• UDI-Public: 10381780025818
• Combination Product (Y/N): N
• PMA/510(K) Number: K071458
• 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): 08/05/2022

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: A2020
• Device Catalogue Number: A2020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/05/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown