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

Catalog Number	A1018
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 2 of 4 reports linked to mfg report numbers: 3004608878-2023-00242, 3004608878-2023-00244, 3004608878-2023-00243.A facility reported that during a posterior cervical laminectomy with laminoplasty procedure, the mayfield swivel adaptor (a1018) slipped, resulting in a 1-2cm laceration on the right side of the patient's head.No intervention was performed.However, the patient had to be transferred back to litter until another mayfield could be obtained resulting in surgical delay of approximately 2 hours while the patient was intubated.The patient was discharged the following day without further issue.Patient is caucasian, 'not hispanic or latino.'.
Additional Manufacturer Narrative
The mayfield swivel adaptor (a1018) was returned for evaluation: failure analysis - investigation of the returned unit was unable to duplicate slippage when all components were put together.However, the unit had some wear on the starburst teeth of the swivel sleeve.Since the unit is over 10 years old (manufactured in 2008), we can no longer service it.Consequently, the unit will not be repaired and will be returned to the customer after the quality engineering investigation.Root cause - the complaint is not confirmed.The probable root cause of the reported complaint is improper or suboptimal position of the skull clamp on the patient.The unit is 15 years old and exceeds integra's 10-year service life and cannot be serviced for repairs any longer.Due to a patient being injured from the slippage, the unit will be sent to quality engineering for further investigation.No correction action 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
• Common Device Name: 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: 18430870
• Report Number: 3004608878-2023-00245
• Device Sequence Number: 8173813
• 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): 01/02/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 01/02/2024
• 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
• Patient Sex: Female