MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SWIVEL ADAPTOR A1018

Catalog Number	A1018
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 3 of 3 reports linked to mfg report numbers 3004608878-2026-00018 and 3004608878-2026-00019: a facility reported that the patient was in the prone position for a craniotomy procedure and slipped from the mayfield swivel adaptor (a1018).This resulted in an inch and a half deep laceration to the patient's left scalp which required suturing.Additional information has been requested.
Additional Manufacturer Narrative
The mayfield swivel adaptor (a1018) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the reported complaint is confirmed from the evaluation.The unit has worn teeth on the swivel sleeve, the threads on the torque knob are damaged, and the washers and retaining rings are worn.Further, since a patient injury was involved, the unit was sent to quality engineering (qe) for further investigation.Qe confirmed the initial findings of the service team and also noted that the unit is heavily worn.To resolve the issues, the swivel sleeve, washers, retaining rings and label will be replaced.Root cause - the complaint is confirmed via inspection of the unit due to being heavily worn with damaged torque knob threads.The probable root cause is routine wear and rough handling of the unit.Additionally, improper or suboptimal placement of the mayfield system can contribute to movement of slippage of the patient.No further corrective action beyond the aforementioned repairs 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 SWIVEL ADAPTOR A1018
• 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: 24405363
• Report Number: 3004608878-2026-00017
• Device Sequence Number: 9905136
• Product Code: FWZ
• UDI-Device Identifier: 10381780267515
• UDI-Public: 10381780267515
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A1018
• Device Lot Number: 135775/161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2016
• 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 (A1059); MAYFIELD ULTRA BASE UNIT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown