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

Catalog Number	A3101
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
This is 1 of 3 reports linked to mfg report numbers: 3004608878-2024-00163 3004608878-2024-00164.A facility reported that the mayfield base unit (a3101) malfunctioned during surgery causing the patient to slip.No information on patient injury or surgical delay has been provided.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.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 of the returned unit showed worn starburst teeth on the transitional, missing end cap on the left bracket side, and the handle tested low when put under pressure.Additionally, the unit was received without the a3018 swivel adapter.Root cause - the complaint is confirmed via inspection of the unit.Probable root cause is routine wear and improper disassembly of the unit.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• 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 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20958631
• Report Number: 3004608878-2024-00162
• Device Sequence Number: 8244319
• Product Code: FWZ
• UDI-Device Identifier: 10381780268161
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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 Catalogue Number: A3101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MAYFIELD SKULL CLAMP (A3059).; MAYFIELD SWIVEL ADAPTOR (A3018).
• Patient Sex: Unknown