MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Model Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem Skull Fracture (2077)

Event Date 03/09/2023

Event Type  Injury  

Event Description

A facility reported that the neurosurgeon was placing the mayfield modified skull clamp (a1059) and mayfield pediatric pins were used for the craniotomy procedure.Torque pressure which is typically 40 pounds of pressure (two black lines visible on the torque screw) indicated 20 pounds per line.They believed that before the surgeon reached the 40 pound torque pressure mark, there was fracture of the skull of a four year old child (gender unknown).Additional information has been requested.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - evaluation found no device deficiencies that would have contributed to the reported complaint and was unable to duplicate the reported issue.The patient's skull was fractured under 40lbs of pressure, and the unit has slight movement in the lock, but when properly positioned and put under pressure it will not move.The unit passes all specific functional testing.The unit has no service history, so it is recommended that a preventative maintenance be performed at this time.Unrelated to the reported issue, investigation showed that the lock had both rotational and lateral movement and a residue buildup was present.Upon disassembly, it was noted that the index knob and the lock needed new components added to replace worn internal parts.As a result, the unit was machined to have heli-coils added to large starburst threads; new components were added to replace worn internal parts, and general maintenance and cleaning were performed.Root cause - the reported complaint is not confirmed.Probable root cause is improper placement or use of the skull clamp on the patient.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

N/a.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 16645930
• MDR Text Key: 312346447
• Report Number: 3004608878-2023-00050
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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
• Patient Age: 4 YR