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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that while the patient was being positioned in the mayfield infinity skull clamp (a1114), too much pounds of pressure was applied to the patient.No information on patient injury or surgical delay was provided.Additional information has been requested.
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
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 - the investigation of the returned unit showed that the lock has both rotational and lateral movement and a residue buildup was present; however, when the unit was locked down under pressure, it did not move.Unrelated to the reported issue, the index knob and the lock needed new components added to replace worn internal parts, and machining was required to have heli-coils added to large starburst threads.All worn components were replaced with new parts, and general cleaning and maintenance were performed.Root cause - the complaint cannot be confirmed.When the unit was received, it had the pediatric 18lb torque knob in the ratchet extension, but this would be the wrong torque knob to be used for an adult skull because the torque knob would not provide sufficient pressure to hold an adult head.Therefore, probable root cause of the reported complaint is improper placement of the skull clamp on the patient.Additionally, the unit is at the end of its repair life; therefore, this will be the last time the unit will be repaired due to age.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.

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19096269
• Report Number: 3004608878-2024-00049
• Device Sequence Number: 15418525
• 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): 06/11/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A1114
• Device Lot Number: 139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2013
• 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