MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SWIVEL ADAPTOR; N/A

Catalog Number	A1018
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is linked to mfg report numbers 3004608878-2024-00018 and 3004608878-2024-00019: a facility reported that during use of the mayfield swivel adaptor (a1018) the staff assisted in turning the patient to the prone position onto the operative table, and upon adjusting the head clamp to the desired position, staff noticed the clamps shifting and not adequately locking.The head pins and clamp were repositioned and applied; however, the positioning was still not optimal.Bleeding from pin sites occurred and original pin sites were stapled closed.A replacement headrest was used and the mayfield pins, base and clamp were quarantined.
Additional Manufacturer Narrative
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 - investigation of the returned unit found no device deficiencies that would have contributed to the reported complaint, and no issues were observed.The swivel adapter functions as it should; the swivel sleeve spins freely and locks into position when attached to the 6in transitional.The teeth on both the sleeve and body are in good shape and do not move when meshed together.The unit was last serviced in july 2023; therefore, it is recommended that the unit be serviced as a precaution.The swivel sleeve, washers, retaining rings and label were all replaced, and general cleaning and maintenance were performed.Further, since an injury has been reported, the unit was sent to quality engineering (qe) for further investigation, and qe confirmed the findings of the initial investigation, and no additional deficiencies were noted.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.The probable root cause of the reported complaint is improper or suboptimal positioning of the patient in the skull clamp.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: N/A
• 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: 19051004
• Report Number: 3004608878-2024-00045
• Device Sequence Number: 15292308
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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
• Device Lot Number: 191112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2019
• 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: A1059 MAYFIELD MODIFIED SKULL CLAMP; A2101 MAYFIELD ULTRA BASE UNIT
• Patient Sex: Unknown