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

Catalog Number	A1018
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports linked to mfg report number 3004608878-2025-00206: a resident physician reported that the mayfield swivel adaptor (a1018) was used for a case along with the integra mayfield bed attachment, base unit, skull clamp, and pins.The resident placed the skull clamp and it was checked by the attending surgeon.During the case, they felt something shift and checked the patient¿s head position within the skull clamp and it was the same; nothing moved.At the end of the case when the patient was flipped to the bed and the skull clamp was removed, the resident noticed an indentation on the patient¿s nose.The round connection point where the skull clamp meets the swivel adaptor was pressing against the patient¿s nose.The resident confirmed the extra pop feeling when locking the skull clamp and there was no play in the mayfield set up.He also checked the patients scalp for any lacerations and there were none.The base unit used in this procedure is unknown, as it was not flagged with the other equipment after the procedure.No surgical delay was reported.
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 - inspection of the returned unit shows damaged teeth on the swivel sleeve, and the washers and retaining rings are worn.Due to the nature of the customer's complaint, the unit was sent to quality engineering (qe) for further investigation.Further investigation by qe confirms the initial findings, that the swivel adapter is in worn/used condition with damage to the starburst teeth.To resolve the issues, by the completion of service, the swivel sleeve, washers, retaining rings and label will be replaced.Additionally, it is recommended that the unit is serviced before returning to the customer.Root cause - the complaint is confirmed via the inspection.The swivel sleeve has damaged teeth that is not allowing it to fully lock onto the clamp.The probable root cause is damage from rough or improper handing 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.

• Brand Name: MAYFIELD SWIVEL ADAPTOR
• Common Device Name: SKULL PINS
• 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: 23437751
• Report Number: 3004608878-2025-00207
• Device Sequence Number: 17301347
• 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
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: A1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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: A1059 MAYFIELD MODIFIED SKULL CLAMP; UNKNOWN MAYFIELD BASE UNIT
• Patient Sex: Unknown