MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MODIFIED SWIVEL ADAPTOR; MAYFIELD

Catalog Number	A1115
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The modified swivel adaptor (a1115) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned unit shows a missing retaining pin to hold the swivel sleeve on.The unit had excessive wear on the swivel teeth, the torque knob had damaged threads and the washers and retaining rings are worn.By the completion of service, the swivel sleeve, retaining pin, washers retaining rings and label, will be replaced along with general maintenance and cleaning.Root cause - the complaint is confirmed via inspection of the unit.The probable root cause is routine wear and improper/rough handling of the unit.No further corrective action 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.
Event or Problem Description
A facility reported that the modified swivel adaptor (a1115) came apart when the patient was, being positioned for a craniotomy procedure.There was a brief delay until another positioner was found and replaced.There was no patient injury.

• Brand Name: MODIFIED SWIVEL ADAPTOR
• Common Device Name: MAYFIELD
• 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: 24011581
• Report Number: 3004608878-2025-00245
• Device Sequence Number: 13097165
• Product Code: FWZ
• UDI-Device Identifier: 10381780267782
• UDI-Public: 10381780267782
• 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
• Report Date (Section B): 01/08/2026

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: A1115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2018
• 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