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

Catalog Number A3059

Device Problems Device Slipped (1584); Mechanics Altered (2984)

Patient Problem Laceration(s) (1946)

Event Date 07/26/2023

Event Type  Injury  

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 showed that the returned unit had no movement in the lock or 80lb torque knob.The 80lb torque knob passed all specific functional testing and did not slip.The clamp was tested on the block at 80lbs and did not slip; the block was rotated several times and locked and unlocked, and there was no slippage.Unit was serviced a year ago and has passed all specific functional testing.Consequently, the unit will be returned to the customer at this time not needing any repairs.However, general cleaning has been performed.Root cause - the reported complaint could not be confirmed as the evaluation could not identify any device deficiencies that would have lead to slippage and therefore a laceration.The issue of this mayfield device being loose and slipping is most likely due to sub-optimal placement.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

A facility reported that patient was prone after applying the mayfield composite series skull clamp (a3059), and the surgeon stated that while positioning the patient, the bolt came loose and slipped.The surgeon claimed that it was tight and locked.Additionally, the surgeon mentioned that this was not the first instance of the skull clamp spontaneously loosening during procedures.This incident caused a superficial laceration to patient's scalp.Additional information has been requested.

• 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: 17664699
• MDR Text Key: 322435290
• Report Number: 3004608878-2023-00162
• 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: 08/31/2023

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
• Date Returned to Manufacturer: 08/16/2023
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• 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