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

Model Number A1018

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

This is 3 of 3 reports linked to mfg report numbers: 3004608878-2022-00063, 3004608878-2022-00064.A facility reported that the mayfield swivel adaptor (a1018) moved after it was positioned on a patient.No patient injury or surgical delay has been reported.

Manufacturer Narrative

The mayfield swivel adaptor (a1018) was not returned for evaluation after three good faith attempts (gfes) were made.However, the customer provided a video for evaluation, findings are as follows: ailure analysis - the customer provided video of the clamp movement while the patient was positioned.Based on the provided video, there appears to be movement in the skull clamp, specifically movement of the ratchet extension.No serial numbers have been provided for the complaint products of this mayfield system, so the age of the devices and service history cannot be determined at this time.Root cause - complaint confirmed.Customer provided video shows movement of the mayfield system after positioning on the patient.However, the definite root cause cannot be identified as the device was not returned.Based on the reported complaint and video, probable root cause is routine wear and lack of preventive maintenance resulting in minor movement within the mayfield.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: MAYFIELD SWIVEL ADAPTOR
• Type of Device: SKULL PINS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14105192
• MDR Text Key: 289226270
• Report Number: 3004608878-2022-00065
• Device Sequence Number: 1
• Product Code: FWZ
• UDI-Device Identifier: 10381780267515
• UDI-Public: 10381780267515
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1018
• Device Catalogue Number: A1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1