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

Catalog Number	A1108
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
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 during application of the mayfield triad skull clamp (a1108) to the patient's head, the pin pops off.There was a 10 minute delay to remove the skull clamp, grab a new one and reapply to patient's head.Patient was safe.
Additional Manufacturer Narrative
The mayfield triad skull clamp 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 device could not duplicate the "pin popping off." when the clamp is properly positioned and put under pressure, it did not move.The clamp does have movement in the lock, but that would not cause the pins to pop out.Unrelated to the complaint issue, the lock has both rotational and lateral movement and a residue buildup is present.Also, the index knob and the lock will need new components added to replace worn internal parts and the unit will need to be machined to have heli-coils added to large starburst threads.Root cause - the reported complaint issue is not confirmed.Probable root cause of the lock movement is routine use and wear of the clamp.The unit is 2 years old and should receive a preventative maintenance service at least once a year.No further investigation is 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
N/a.

• 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 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: 20973142
• Report Number: 3004608878-2024-00167
• Device Sequence Number: 20923167
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: A1108
• 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: 11/29/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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 Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic