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	Laceration(s) (1946)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield triad skull clamp (a1108) 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.The unit had little movement in the lock, but when the unit was put under pressure, it did not move.Since there was report of patient injury, the unit was sent to quality engineering (qe) for further investigation.Qe confirmed the findings of the service & repair report with no additional device deficiencies observed.Unrelated to the complaint issue, all worn components were replaced with new parts, and general cleaning and maintenance were performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Probable root cause of the reported complaint is improper or suboptimal placement of the skull clamp.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
A facility reported that the patient's head was pinned in the mayfield triad skull clamp (a1108) in supine position and was then flipped to reposition in prone position.The surgeon was holding the clamp-patients head (before connecting to the swivel adaptor) and the patient's head slipped from the clamp causing laceration.The patient's scalp was stitched and was then re-pinned in another clamp.Additional information was received as follows: 1.Was there a delay in surgery due to product problem? if yes, how long? >> yes there was delay.Approximately 30 minutes.2.Was revision/medical intervention required? if yes, what revision/medical intervention was performed? >> the clamp disengaged from the patient after they were pinned.This disengagement caused a laceration on the right parietal portion of patient's skull.[redacted] had to repair the laceration with suture.This approximately took 20 minutes.The patient then needed to be re-pinned and positioned after repair of the laceration.It took approximately 10 minutes to re-position the patient to continue on with surgery.3.Patient outcome.>> surgery was completed on patient as scheduled.Patient is doing fine as far as we know after surgery.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Medwatch (mw5157080) was received with subsequent information: patient's head was pinned in supine position, 3-point mayfield head holder, patient was then turned prone.Surgeon was holding the patient's head (before connecting to swivel adapter) and while positioning her with the mayfield and flexing her neck, the mayfield head holder pins slipped, resulting in a 5 cm occipital region laceration.Laceration repaired and patient's head was re-pinned in another mayfield device.Procedure continued as planned.

• 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: 19760657
• Report Number: 3004608878-2024-00079
• Device Sequence Number: 12956407
• 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): 08/23/2024

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: A1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White