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

Model Number A1059

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skull Fracture (2077)

Event Type  Injury  

Event Description

A facility reported that skull fracture on a patient was verified via ct scan post placement of mayfield modified skull clamp (a1059).The facility's clinical engineers found that the skull clamp was in good working order and that the torque knob pressures were well within specification.However, evaluation was requested.

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: failure analysis: evaluation confirmed that the unit needed repair.Unit received with the lock having both rotational and lateral movement and a residue buildup was present.Upon disassembly, repair noted the index knob and the lock needed new components added to replace worn internal parts.Unit was machined to have heli-coils added to the large starburst threads.General cleaning performed and worn internal parts were replaced.Unit was sent to quality engineering for further investigation due to a skull fracture post placement and further investigation by quality engineering confirms the findings from the service & repair evaluation, no additional device deficiencies found.Root cause: the unit passed all specific functional testing requirements, except for the lock having rotational movement due to routine use and wear - unit is beyond integra¿s 7 years recommended life cycle (manufactured 2011).When the unit is properly positioned and put under pressure the unit will function properly.Probable root cause for the reported complaint is improper setup of the skull clamp on the patient.No corrective or preventive action is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• 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: 15176132
• MDR Text Key: 297347218
• Report Number: 3004608878-2022-00157
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1059
• Device Lot Number: 119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/05/2022
• 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