MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY SKULL CLAMP; N/A

Model Number	A1114
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a1114) was returned for evaluation: device history record (dhr) review - lot number information has been provided; therefore, the dhr was reviewed and found no anomalies.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 except for the lock having rotational movement when the unit is not under pressure.However, this would not have caused a slippage.When the unit is properly positioned and put under pressure, the unit will function properly, the unit will function properly.Unit received with case, all rocker arm assemblies and adult and pediatric torque knobs.General maintenance and cleaning required.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Service and repairs could not duplicate slippage.However, a probable root cause for the this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
A facility reported that mayfield infinity skull clamp (a1114) was used for a craniotomy procedure, and the patient was pinned in routine fashion and stability was verified by both attending surgeons.No wiggle was identified prior to prepping and draping.Midway through the case, the patient's head slipped and clearly sunk lower to the ground.Upon immediate examination, it was noted that the double pin site had moved, lacerating the galea through the cranium.Additional information indicated that the patient required repositioning once the clamp was removed to perform a multilayer closure of the approximately 2-inch-long laceration of the scalp.The patient was discharged in normal fashion post-operatively in accordance with her diagnosis, this incident did not prolong her in-patient status.No surgical delay has been reported.

• Brand Name: MAYFIELD INFINITY SKULL CLAMP
• 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: 13720242
• Report Number: 3004608878-2022-00039
• Device Sequence Number: 6091260
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• Combination Product (Y/N): N
• PMA/510(K) Number: K051440
• 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): 03/10/2022

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: A1114
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2017
• 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