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	Insufficient Information (4580)
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
A facility reported that the mayfield swivel adaptor (a1018) gave way during surgery.Additional information has been requested.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.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 - evaluation of the swivel adapter showed both torque screws are damaged, the lower torque screw threads are worn off, the upper torque screw has deep damages at the tip of the threads, both torque screws need to be replaced, and the serial label is worn off and needs to get replaced.Additional retainer rings, nylon washers, label and retaining pin need to get exchanged, and the unit will be marked with instance number and a function test is required to be performed.As a result, the unit was returned unrepaired and is no longer allowed to be used for medical purposes.Root cause - the complaint is confirmed via inspection of the unit.The unit has damaged components and also needed replacement of worn components.The probable root cause is rough or improper handling 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 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: 21985212
• Report Number: 3004608878-2025-00097
• Device Sequence Number: 14572458
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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