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

Catalog Number A1059

Device Problem Mechanical Problem (1384)

Patient Problems Hemorrhage/Bleeding (1888); Needle Stick/Puncture (2462)

Event Date 06/02/2021

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 torque screw on mayfield modified skull clamp (a1059) was over tightened during a posterior fossa lesion resection (pediatric case).The issue was discovered when the patient was prepped for surgery and mayfield skull clamp was set up on patient.The surgeon noticed oozing of blood or cerebrospinal fluid (csf) at the skull pin site.The surgeon immediately stopped and ordered an urgent ct scan.The patient was transferred to ct.Ct scan showed no damage or fracture to cranial bone.Patient returned to theatre and procedure continued.The surgeon used a different skull clamp and new pins which means additional pin sites on the patients skull; the surgeon satisfactorily completed the procedure.There was slightly more than one hour surgery delay.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h6, h10.The mayfield modified skull clamp (a1059) was returned for evaluation.Failure analysis - the device was not fit for clinical use as the rollover to lock is binding and may not have been correctly locked when in use.The device required general service, replacement of damaged torque screw, and ratchet extension which are >10 years old and other parts.Root cause - the reported complaint was confirmed.Evaluation showed that parts of the device are damaged and worn.The definite root cause of the observed condition cannot be reliably determined but it is likely caused by wear and tear or improper handling.The unit needs repair, and replacement of worn parts.General maintenance and cleaning are required.Device exceeds its expected life of 7 years (sold on feb 25, 2020) and replacement is highly recommended.

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
• MDR Report Key: 12089219
• MDR Text Key: 264976007
• Report Number: 3004608878-2021-00430
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 08/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR