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

Catalog Number A1059

Device Problems Decrease in Pressure (1490); Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 06/30/2016

Event Type  Injury  

Event Description

The a1059 mayfield modified skull clamp pin had slipped and caused a laceration on a female patient.The incident took place on (b)(6) 2016 when a craniotomy was being performed.Upon initial placement of the skull clamp, 60 pounds of pressure was applied to the torque screw and then the patient was draped and prepped for surgery.The surgeons left the operating room to scrub and when they returned they noticed that the pressure had fallen to 20 pounds.They tried to re-apply pressure and when they did they could only attain 40 pound.They investigated further to find that the pin had slipped and caused roughly a 2 cm laceration in the scalp.They had to remove the clamp, suture the laceration and reposition the patient.Additional information has been requested.

Manufacturer Narrative

Additional information was received on 26jul2016: the patient's underlying medical condition was a glioblastoma multiforme.The patient's outcome was good but she required suturing of the laceration caused by the pin slippage and the surgery time was delayed by 45 minutes.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(4) 2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the complaint was not confirmed and no issues observed.The unit was cleaned per protocol.With respect to the returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement, this would not have caused a slippage; when unit is properly positioned and put under pressure unit would not have slipped.General maintenance and cleaning required.Device history record reviewed for this product id lot code 077 manufactured on 30-sep-2007 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.No manufacturing or design related trend has been identified.Conclusion: in summary we are unable to confirm or duplicate the end users experience.The returned unit passed all functional testing requirements, however general maintenance is required.

• 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 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5806846
• MDR Text Key: 49945307
• Report Number: 3004608878-2016-00192
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2016

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: 07/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/16/2016; 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2007
• 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 Outcome(s): Required Intervention