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

Model Number A2000

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Event 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.

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
• 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: 15827404
• MDR Text Key: 308002543
• Report Number: 3004608878-2022-00247
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253655
• UDI-Public: 10381780253655
• Combination Product (y/n): N
• PMA/PMN Number: K932807
• 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: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2020
• 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