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

Model Number A1059

Device Problem Unintended System Motion (1430)

Patient Problem Laceration(s) (1946)

Event Date 04/21/2023

Event Type  Injury  

Event Description

A facility reported that during use of the mayfield modified skull clamp (a1059) a patient damage occurred.Additional information was received with the following details: when was the patient injured? (when inserting the head into the system, during surgery, when removing the head from the system)? ¿ as explained in the short description, after clamping the head, locking the two-thorn and fixing the mayfield to the operating table, the two-thorn occurred and the mayfield jumped open (from 80 nm to 20 nm).How the patient was injured (slipping, ¿): - the jumping of the mayfield caused a rotational movement of the two-thorn, resulting in an approx.1 cm long cut.Can you please describe the injury? - a skin injury with a puncture component (through the thorn) and a cut component due to the slipping of the thorn can you please describe the treatment of the injury? - disinfection and wound care with skin suture in single button technique.How is the patient doing? - except for the skin injury, the patient is doing well was the patient a child, a teenager, an adult, an elderly person? ¿ this is a middle-aged man.Has the operation been postponed due to the problem? if so, how often? -no.However, the patient had to be unclamped and clamped again.Was another device available to complete the operation? the operation could be carried out after extensive testing after re-application of the same mayfield.The mayfield was pulled several times until it was properly engaged.

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 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 - investigation of the returned unit showed that the plain bearing surface of the base cast has dents.Furthermore, one of the internal threads in the center of one of the two gear teeth was damaged.To resolve all issues, the base of the skull clamp was replaced along with the hardware needed to adjust the swivel lock.The skull clamp has been marked and successfully tested.Root cause - complaint confirmed via inspection of the unit.There was play in the lock and a buildup of debris.Opening the mechanism found dents on the bearing surface and damage to one of the internal threads.Probable root cause is routine use and wear of the skull clamp.Additionally, improper or suboptimal placement of the skull clamp can result in slippage or movement of 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.

• 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: 16953481
• MDR Text Key: 315470933
• Report Number: 3004608878-2023-00089
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• 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?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• 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 Sex: Male