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

Model Number	A2114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
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
A facility reported that the patient moved and was cut when placed in the mayfield infinity xr2 skull clamp (a2114).No delay in surgery has been reported.Additional information has been requested regarding patient injury.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.Additional information has been received as follows: 1.What was the length of time the product was in use before the event the clamp was on for approximately 15 minutes when the patient's head slipped out.2.Was there any surgical delay in the procedure?.There was at least a surgical delay of 40 minutes while we changed to use the other system.3.What action was taken after the product problem occurred? (e.G.Adjustments made, replacement of device, etc.).The patient's head was immediately supported by dr.Obasi and we applied pressure to slice in the scalp.Staples were used to close the approximately 2" laceration.4.Extension of the injury.Deep laceration approximately 2" that needed to be closed with staples.5.Do you have pictures of the injury? no pictures were taken.6.What was the outcome for the patient, how is the patient doing now? the laceration healed well.Investigation findings: 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- complaint confirmed via inspection of the unit.Unit received had the 80lb torque knob disassembled and cleaned thoroughly due to having residue build up inside it.Both the right and left pawls was replaced due to wear.The set screw was replaced due to the index knob being too loose.Unit was received with a black case and two adult rocker arm assemblies.General maintenance and cleaning performed.All worn components were replaced with new parts.Further investigation by quality engineering confirms the s&r evaluation, no additional device deficiencies noted.Root cause- probable root cause is routine use and wear.The 80-pound torque knob was seized and would not move.The unit required disassembly, cleaning, and replacement of worn parts.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: 15827998
• Report Number: 3004608878-2022-00250
• Device Sequence Number: 17681514
• Product Code: HBL
• UDI-Device Identifier: M268A21141
• 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): 12/16/2022

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: 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: 10/28/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2012
• 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