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

Model Number	A1018
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
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
This report is 2 of 3 and linked to mfg report numbers 3004608878-2023-00014 and 3004608878-2023-00016: a facility reported that while the mayfield system (a1018 mayfield swivel adaptor) was in contact with a patient for an unspecified procedure, a problem occurred and the patient was injured.Additional information received states that "when palpating the anatomical relationships, the patient's head in the mayfield had moved 15 degrees from the (horizontal) position." the problem led to increased surgery time.
Additional Manufacturer Narrative
The mayfield swivel adaptor (a1018) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.The device passed all specific functional testing requirements.No repairs are needed at this time.Root cause - complaint not confirmed.Evaluation of the returned unit found no defects.Probable root cause for the reported complaint is improper or suboptimal positioning of the mayfield system on the patient.No further investigation 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
N/a.

• 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: 16301169
• Report Number: 3004608878-2023-00015
• Device Sequence Number: 6075420
• 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,Followup
• Report Date (Section B): 03/17/2023

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 Model Number: A1018
• Device Catalogue Number: A1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 02/04/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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: A1018 MAYFIELD SWIVEL ADAPTOR; A2101 MAYFIELD ULTRA BASE UNIT
• Patient Sex: Unknown