MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Model Number	A2000
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the rocker arm on mayfield 2000 skull clamp (a2000) was loose even after locking the knob.There was a delay for 10 minutes with no patient injury.The device was changed and surgery was performed with another device.
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The mayfield 2000 skull clamp (a2000) was returned for evaluation: failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.Unit received had the swivel base and piston replaced due to wear.The plastic hex bushing was replaced due to the rocker arm assembly having rotational movement while in the locked position.General maintenance performed and all worn components were replaced with new parts.Root cause analysis: complaint was confirmed via inspection of the unit.The rocker arm assembly had rotational movement while in the locked position.Unit required replacement of worn components.Unit is beyond integra's 7 years recommended life cycle (manufactured in 2008).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 2000 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: 14283072
• Report Number: 3004608878-2022-00081
• Device Sequence Number: 4859393
• Product Code: HBL
• UDI-Device Identifier: 10381780253655
• UDI-Public: 10381780253655
• Combination Product (Y/N): N
• PMA/510(K) Number: K932807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: A2000
• Device Catalogue Number: A2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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