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

Model Number	A1108
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 - complaint confirmed via inspection of the unit.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 and maintenance performed and worn internal parts were replaced.Root cause - complaint confirmed via inspection of the unit.There was movement present in the lock and the index knob and lock needed new components added to replace worn internal parts due to routine use and wear.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 or Problem Description
A facility reported that the lock on the mayfield triad skull clamp (a1108) would not stay locked or hold when patient was moving.This occurred during a procedure with no patient harm, and delay in surgery is unknown.

• Brand Name: MAYFIELD TRIAD SKULL CLAMP
• Common Device Name: 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: 15176135
• Report Number: 3004608878-2022-00156
• Device Sequence Number: 5121265
• Product Code: HBL
• UDI-Device Identifier: 10381780253518
• UDI-Public: 10381780253518
• Combination Product (Y/N): N
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2022

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
• Operator of Device: Health Professional
• Device Model Number: A1108
• Device Catalogue Number: A1108
• Device Lot Number: 184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown