MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ¿MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD¿; ¿COMPOSITE SERIES¿

Model Number	A3101
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported that the mayfield composite series base unit (a3101) was wobbling during a "craniotomy for lesion" procedure, the "teeth" or starbursts was not gripping in.There was a minimal delay in surgery to stabilize the unit.The patient had already been pinned in the clamp, so they continued with the case.There was no patient injury or death reported.
Additional Manufacturer Narrative
The mayfield composite series base unit (a3101) was returned for evaluation: device history record (dhr)- the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation showed that the two halves of the swivel adaptor do not close, and the paint had bubbled.The estimated life expectancy for mayfield products is 7 years in consideration of all the variables that can influence the life and function of these devices.Root cause - complaint confirmed via inspection of the unit.Probable root cause is routine use and wear.Additionally the paint had bubbled on the base unit and as a result the unit was replaced for a new a3101.Corrective and preventative action (capa) related to the powder coat peeling on the a3101 base units is in process; therefore, this complaint is being closed.
Event or Problem Description
N/a.

• Brand Name: ¿MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD¿
• Common Device Name: ¿COMPOSITE SERIES¿
• 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: 15512894
• Report Number: 3004608878-2022-00198
• Device Sequence Number: 14745329
• Product Code: FWZ
• UDI-Device Identifier: M248A31011
• UDI-Public: 10381780268161
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: A3101
• Device Catalogue Number: ¿A3101¿
• Device Lot Number: SB203689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2020
• 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