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	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
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
This is 1 of 2 reports linked to mfg report number 3004608878-2023-00249: a facility reported that the mayfield triad skull clamp (a1108) slipped on a patient during an unspecified case.Additional information has been received stating "to my knowledge this had no impact on the surgery or the patient.It was brought to the office without much information on the problem." no information has been provided on surgical delay.
Additional Manufacturer Narrative
The mayfield triad skull clamp (a1108) was returned for evaluation: failure analysis -evaluation of the returned unit was unable to duplicate slippage.However, the evaluation showed that there was slight rotational and lateral movement in the lock, the large starburst threads were showing some signs of wear, the ratchet extension showed signs of hammering marks on the top back of it, and the plunger assembly was sticking.Additionally, the unit has not been serviced in over a year.To resolve the wear issues found, the roundhead screw, adjustment screw, label, screw, nut, washers, o-ring, ball bearings, wave springs and helicoils will be replaced along with general cleaning and maintenance.Further, the unit was sent to quality engineering for further investigation and the findings of the service & repair report were confirmed by quality engineering with no additional device deficiencies observed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint as slippage could not be duplicated.The clamp has slight rotational movement, but when the clamp is properly positioned and put under pressure, it will not move.Probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp on the patient.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.

• 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: 18461018
• Report Number: 3004608878-2023-00248
• Device Sequence Number: 17928414
• 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,Followup
• Report Date (Section B): 01/19/2024

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: A1108
• Device Lot Number: 124
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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