MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD TRIAD SKULL CLAMP; N/A

Catalog Number	A1108
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the plunger on the mayfield triad skull clamp (a1108) released while the patient's head was in the clamp.There was no patient injury.Additional information has been requested.
Additional Manufacturer Narrative
The mayfield triad skull clamp (id a1108) 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 had both rotational and lateral movement and a residue buildup was present.The index knob and the lock needed new components added to replace worn internal parts, and the unit needed to be machined to have heli-coils added to large starburst threads.The unit has not been serviced since february of 2023 and it is recommended to be serviced every year.All worn components were replaced with new parts, and general cleaning and maintenance were performed.Root cause - the complaint is confirmed is via inspection of the unit.The plunger assembly is causing the ratchet extension to slip, and the unit required replacement of worn components.Additionally, the unit needed annual preventive maintenance.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.
Additional Manufacturer Narrative
Updated fields: a2, a3a, a4, a6, g3, g6, h2, h6 (impact code), h11.Additional information received as follows: 1.Was there a delay in surgery due to the product problem? yes.(a) if yes, how long in minutes? 5 to 10 minutes.2.How was the procedure completed? we had to go under drapes, reapply a different skull clamp, attach to base.Due to having to reapply the clamp, we lost navigation and was not able to navigate the procedure.3.Please provide patient information (gender, age, weight, ethnicity, race) female / 43 y/o, 5¿11 and 121 kg / white.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD TRIAD SKULL CLAMP
• Common Device Name: N/A
• 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: 19279044
• Report Number: 3004608878-2024-00058
• Device Sequence Number: 6358401
• 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): 05/17/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/17/2024
• 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
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 121 KG
• Patient Race: White