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	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the mayfield 2000 skull clamp (a2000) was on a patient and there was a little movement of the locking mechanism.There was no patient injury noted and no delay in surgery has been reported.
Additional Manufacturer Narrative
The mayfield skull clamp (a2000) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the complaint is confirmed via inspection of the unit.The investigation showed that the lock had rotational and lateral movement due to a worn hex bushing.To resolve the issue, new components were added to replace all worn internal parts, and general maintenance and cleaning has been performed.Root cause - root cause is routine use and wear of the unit as the bushing was worn resulting in movement in the lock while in the locked position.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 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: 15827404
• Report Number: 3004608878-2022-00247
• Device Sequence Number: 20333127
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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
• Device Lot Number: 201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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