MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Model Number	A2114
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that during a cranial aneurysm procedure, the mayfield infinity xr2 skull clamp (a2114) slipped causing a superficial laceration to the patient.Additional information received indicates that the pin did shift into the sterile field, and that when this was discovered, they removed the pins from the patient's head and rested it on the headboard as they closed the patient.This was discovered at the end of case; the shift must have happened early in the case and they thought the patient had coughed.There was no delay in the procedure as it happened intraoperatively.
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.
Additional Manufacturer Narrative
The mayfield infinity xr2 skull clamp (a2114) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - on investigation of the returned device, the slippage complaint could not be duplicated.However, it was noted that the right and left pawls were cracked.These were both replaced.The 80lb torque knob was disassembled due to having a residue present inside.The set screw was also replaced due to a loose index knob.All worn components were replaced with new parts.General maintenance and cleaning performed.Unit was not received with the black case.Root cause - compliant could not be confirmed via inspection of the unit.None of the above listed findings were cause for slippage, and when the unit was tested, the slippage issue could not be duplicated.When pressure is applied to the unit after it is positioned properly, the unit does not slip.No further investigation 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 INFINITY XR2 SKULL CLAMP
• Common Device Name: MAYFIELD
• 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: 16598554
• Report Number: 3004608878-2023-00046
• Device Sequence Number: 4572205
• Product Code: HBL
• UDI-Device Identifier: 10381780253761
• UDI-Public: 10381780253761
• Combination Product (Y/N): N
• PMA/510(K) Number: K130389
• 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,Followup
• Report Date (Section B): 04/21/2023

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: A2114
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2018
• 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