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

Catalog Number	A1114
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that the mayfield infinity skull clamp (a1114) slipped resulting in patient laceration.The rocker and single pin were locked, and 60 psi was confirmed.When the patient moved, drapes were removed, and psi was down to 40.Laceration was stapled to close.The patient was re-positioned in a new 3 pin skull clamp, and no issues were noted with the second 3 pin skull clamp.It is unknown if there was any surgical delay.Additional information has been requested.
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
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The mayfield infinity skull clamp (a1114) 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 was unable to duplicate slippage.When the unit was properly positioned and put under pressure, it did not slip.It is noted that the ratcheting of the extension going into the base is really weak, but that would not allow the movement for loss of pressure or slippage.Also, the lock does have a bit of sticking and slight movement, but it would not affect the pressure of the clamp.Since a patient injury occurred, the unit was sent to quality engineering (qe) for further investigation and the initial findings were confirmed by qe with no additional device deficiencies observed.All worn components were replaced with new parts, and general cleaning and maintenance were performed.Root cause - the complaint is not confirmed.However, the probable root cause of the reported complaint is improper or suboptimal positioning of the skull clamp on the patient.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 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 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20803066
• Report Number: 3004608878-2024-00143
• Device Sequence Number: 21315790
• 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,Followup
• Report Date (Section B): 12/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown