MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1059

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the pin side of the mayfield modified skull clamp slipped during a craniotomy procedure resulting in patient laceration, and it appeared that the device was not locking properly.It was further reported that the patient was brought to the operating room, anesthetized and intubated by the anesthesia team.A mayfield head holder was then applied.They turned her prone on to the operating room table with her chest resting on gel rolls.Her head was kept midline and flexed downwards.The mayfield was then fixed to the bed; they then noted that the right frontal pin site had slipped.The mayfield head frame was removed and a small laceration was sutured.A different clamp was used to complete the procedure.They then reapplied the headframe and secured the mayfield to the bed.Once anesthesia was satisfied with positioning and airway was secured, they registered their stealth navigation system and marked off the sub-occipital region area using thousand drapes.The skin was then prepped and she was draped in the usual sterile fashion.They performed the jcaho hard-stop time out and began by instilling local anesthetic.The skin was incised using a #10 blade in an inverted hockey stick fashion towards the right.They carried out the dissection in the midline using monopolar cautery.Self-retaining cerebellar retractors were used to reflect the skin and muscle.They reached the sub-occipital bone and extended their exposure to the inferior edge of the bone and then to the right, laterally.There was surgical delay for a couple minutes.

Manufacturer Narrative

The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: the returned unit has passed all specific functional testing requirements.The slippage could not be duplicated.When unit is properly positioned and put under pressure, unit would not have slipped.Further investigation showed that the lock has rotational and lateral movement and a residue buildup is present.Unit has been repaired and worn parts were replaced.General maintenance performed.Root cause: the evaluation of the device could not duplicate the reported complaint.The slippage could not be duplicated from the functional testing.When unit is properly positioned and put under pressure unit would not have slipped.The definite root cause cannot be reliably determined but it is likely caused by improper usage, and/or placement.However, unrelated to the reported event, the lock has rotational and lateral movement and a residue buildup.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 12631970
• MDR Text Key: 276378734
• Report Number: 3004608878-2021-00596
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• 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: 12/01/2021

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: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2017
• 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