MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; N/A

Model Number A2000

Device Problem Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Manufacturer Narrative

Mayfield 2000 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 - investigation of the returned unit showed that there were damaged threads on the torque knob and the rotator teeth assembly.The torque knob and rotator teeth assembly were replaced as a result.General cleaning and maintenance performed.Root cause - the complaint is confirmed via inspection of the unit.Probable root cause is rough or improper handling of the unit.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 Description

A facility reported that they had a difficult time turning the knob on the mayfield skull clamp (a2000) to increase pressure.The device became stuck at the end and would not unlock, and they had to use a wrench to remove it from the patient's head.No patient injury or surgical delay has been reported.

• Brand Name: MAYFIELD 2000 SKULL CLAMP
• Type of Device: N/A
• 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: 16738763
• MDR Text Key: 313669717
• Report Number: 3004608878-2023-00061
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• 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: 227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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