MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 12/13/2023

Event Type  Injury  

Event Description

A facility reported that the mayfield composite series skull clamp (a3059) lost pressure somehow and released while the patient was still positioned in it.This resulted in a severe laceration of the patients head.Additional information was received indicating the following: 1.Date of incident: (b)(6) 2023.2.Type of procedure performed: awake craniotomy.3.Please provide the size and location of the laceration: unknown.4.Was there a delay in surgery due to product problem? if yes, how long?: no delay.5.Was revision/medical intervention required? if yes, what revision/medical intervention was performed?: yes, staples were used to close the laceration.6.When placing the skull clamp, if you were to draw an imaginary line between the single pin and the rocker arm swivel point, did that imaginary line pass through an axial center of the skull? yes.7.Did each pin engage the cranium in a perpendicular approach? yes.8.Patient outcome.Positive outcome.

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The mayfield composite series skull clamp (a3059) 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 the "clamp releasing when put under pressure." however, unrelated to the complaint issue, it was observed that the base casting has a crack along the backside of the clamp and will need to be replaced as a result.The disk ratchet and retainer are still in good shape, but will need to be replaced when the casting is replaced.By the completion of service, the following components will have been replaced: base casting, disk ratchet and retainer along with general cleaning and maintenance 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 patient in 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 Description

N/a.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• 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: 18461022
• MDR Text Key: 332264236
• Report Number: 3004608878-2024-00001
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253792
• UDI-Public: 10381780253792
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 02/23/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1