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

Catalog Number A1059

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

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 after positioning the patient with the mayfield modified skull clamp (a1059) fixed, the surgeon wanted to test if the clamp was fixed properly and tried to move both arms of the clamp in opposite directions.When doing that the forcescrew went down from 35 to 25.The device was in contact with the patient; however, there was no injury.The event led to increased surgery time for 5 minutes.

Manufacturer Narrative

The mayfield skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device showed that the skull clamp had play in its swivel lock and there was an accumulation of residue.Adjustment required replacing some worn internal parts.The ratchet extension cannot be unlocked properly and got stuck in certain positions; the piston assembly does not move smoothly, the piston pin needed to be replaced and the assembly overhauled.The heli-coil insert protrudes from the ratchet extension, and this is a material defect and must be replaced.As a preventative measure, the torque screw is replaced.The damaged/worn parts were replaced along with general maintenance as the device was under repair for the first time.Root cause - the complaint is confirmed via inspection of the unit.The heli-coil was protruding from the ratchet extension and there was play in the swivel lock and residue buildup present.Probable root cause of the observed device defects is improper seating of the heli-coil and routine wear and tear.Additionally, improper or suboptimal placement of the skull clamp can lead to movement or slippage of the skull clamp and 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: 17509671
• MDR Text Key: 321636004
• Report Number: 3004608878-2023-00152
• Device Sequence Number: 1
• Product Code: HBL
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2023
• 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