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 02/28/2024

Event Type  Injury  

Manufacturer Narrative

The mayfield composite series skull clamp (a3059) was returned for evaluation: device history record (dhr) review - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint, and "slippage" could not be duplicated.However, the unit has a slight movement in the lock while in the locked position and the disk ratchet has moved, and it was observed that the unit has not had any service since it was bought in 2018.Despite the slight movement, when the clamp is properly positioned and put under pressure, it will not move.Further, since an injury has been reported, the unit was sent to quality engineering (qe) for further investigation, and qe confirmed the findings of the initial investigation, noting that the only issue is slight movement in the lock, which is likely due to routine use and wear as the unit had not been serviced since 2018.To resolve the noted issues, the disk ratchet and retaining ring were replaced, and general maintenance and cleaning were performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.The probable root cause 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.

Event Description

This is 2 of 2 reports linked to mfg report number 3004608878-2024-00036 as customer is unable to determine which of their mayfield devices was used: a facility reported that during set up and patient positioning for a chiari procedure, the patient slipped out of the mayfield composite series skull clamp (a3059), causing a laceration.The torque knob malfunctioned and came out once the patient was positioned; the torque knob did not hold the patient in place.Additional information received indicates the following: 1.Type of procedure performed.>> chiari, prone 2.Please supply the lot / serial number of the described device.>> a3059, (b)(6) or (b)(6), unknown which of the 2 was involved in the incident.Both were sent in for inspection.3.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 line of the skull? >> yes.4.Did each pin engage the cranium in a perpendicular approach? >> yes, torque knob malfunctioned and came out once patient was positioned.Torque knob did not hold patient in place.5.Was there a delay in surgery due to product problem? if yes, how long? >> yes, 40mins.6.What is the patient outcome or status of the patient? >> patient had extensive laceration which had to be sutured.Patient is doing ok now.

• 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: 18959712
• MDR Text Key: 338366453
• Report Number: 3004608878-2024-00037
• 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
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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
• Date Returned to Manufacturer: 03/04/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2018
• 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
• Patient Age: 16 YR
• Patient Weight: 122