MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Model Number A2114

Device Problems Device Slipped (1584); Mechanics Altered (2984)

Patient Problem Laceration(s) (1946)

Event Date 10/19/2022

Event Type  Injury  

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 Description

A facility reported that during a craniotomy procedure, mayfield infinity xr2 skull clamp (a2114) slipped.The mayfield was in place on patient with the rotation locked in place and pressure gauge set at 80 pounds on the pin, but while positioning the patient prone, the mayfield swung loose and the ratcheting system also came apart causing scalp laceration to the patient.The laceration was closed with staples and patient was re-pinned and repositioned with a different mayfield.Patient outcome reported as doing fine but has a big laceration on her scalp.

Manufacturer Narrative

Updated fields: g3, g6, h2, h6 (health impact code), h10.Additional information received on 09nov2022: was there surgical delay due to product problem? yes there was a delay of 30 min.We had to re-position and take care of the patient's laceration.

Event Description

N/a.

Manufacturer Narrative

The mayfield infinity xr2 skull clamp (a2114) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: evaluation of the returned skull clamp showed that it was in good working order and passes quality inspection.Also, no maintenance required at this time.Root cause: probable root cause is improper or suboptimal positioning of the skull clamp on the patient.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• 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: 15764922
• MDR Text Key: 303393059
• Report Number: 3004608878-2022-00238
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253761
• UDI-Public: 10381780253761
• Combination Product (y/n): N
• PMA/PMN Number: K130389
• 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,Followup
• Report Date: 01/27/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: A2114
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/09/2022; 01/19/2023
• Supplement Dates FDA Received: 12/07/2022; 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2019
• 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