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	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mayfield swivel adaptor (a1018) was returned for evaluation: failure analysis - the inspection of the swivel adapter shows the threaded end of the torque screw on the base is damaged.The damaged screw must be replaced for the reassembly along with the worn retaining rings and the worn nylon washers.After reassembling the swivel adapter, a function test must be carried out.Root cause - the complaint is confirmed via inspection of the unit.The threaded end of the torque screw on the base was damaged, and the damaged screw needed replacement along with worn components.Additionally, this unit is beyond integra¿s 7 years recommended life cycle (manufactured 2013).The probable root cause is routine use and rough handling.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.
Event or Problem Description
This is 3 of 3 reports linked to mfg report numbers 3004608878-2025-00079 and 3004608878-2025-00080: a facility reported that once fixed, the mayfield swivel adaptor (a1018) was not stable.The problem was found on the patient under anesthesia, before the surgery.Since the patient could not give up this surgery, we minimized the movement of the headboard as much as possible, taking into account its imperfect stability for the entire duration of the surgery.There was no increased surgery time or patient injury.

• 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: 21902065
• Report Number: 3004608878-2025-00081
• Device Sequence Number: 15635646
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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
• Device Lot Number: 137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: A1108 MAYFIELD TRIAD SKULL CLAMP.; A2101 MAYFIELD ULTRA BASE UNIT.
• Patient Sex: Unknown