MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD TRIAD SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Model Number	A1108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	12/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield xtriad skull clamp (a1108) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.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 properly positioned and put under pressure the unit would not have slipped.Unrelated to the complaint issue, upon disassembly, it was noted that the index knob and the lock needed new components added to replace worn internal parts.Unit was machined to have heli-coils added to large starburst threads, general maintenance and cleaning performed and worn components were replaced.Root cause - probable root cause is improper or suboptimal placement of the mayfield system on the patient.Service & repair (s&r) could not duplicate slippage.Further investigation by quality engineering observed no additional deficiencies and confirms the findings of the s&r report.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
This is 2 of 2 reports linked to mfg report number 3004608878-2022-00291.A facility reported that a patient sustained a 2mm laceration during use of the mayfield triad skull clamp (a1108) while being positioned from supine to prone.The treatment required sutures and the mayfield to be removed, which delayed the case about 30 minutes.The patient did well after surgery.

• Brand Name: MAYFIELD TRIAD SKULL CLAMP
• Common Device Name: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 16113916
• Report Number: 3004608878-2022-00292
• Device Sequence Number: 17556454
• Product Code: HBL
• UDI-Device Identifier: 10381780253518
• UDI-Public: 10381780253518
• Combination Product (Y/N): N
• PMA/510(K) Number: PRE-AMEND
• 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): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: A1108
• Device Catalogue Number: A1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2018
• 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