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

Model Number A1108

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

A facility reported that the swivel lock on the mayfield triad skull clamp (a1108) was able to rotate from the locked to unlocked position very easily and did not 'roll' into the locked position.It became unlocked while turning the patient.No patient injury or surgical delay has been reported.

Manufacturer Narrative

The mayfield triad skull clamp (a1108) was returned for evaluation: failure analysis - complaint confirmed via inspection of the unit.The index knob was loose and the unit required replacement of worn internal parts.Unit received with the lock having rotational and lateral movement and a residue buildup was present.New components have been added to replace all worn internal parts, and general maintenance and cleaning also performed.Root cause - complaint confirmed via inspection of the unit.The index knob was loose and the unit required replacement of worn internal parts.This unit is beyond integra¿s 7 years recommended life cycle (manufactured 2010).No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: MAYFIELD TRIAD 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: 13061313
• MDR Text Key: 282634709
• Report Number: 3004608878-2021-00693
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253518
• UDI-Public: 10381780253518
• 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: 12/22/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: A1108
• Device Catalogue Number: A1108
• Device Lot Number: 109(2010)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/22/2021
• 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