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

Catalog Number A1059

Device Problems Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the ratchet extension arm was stiff and does not move smoothly.It almost needed to be hit to move through the casting.The surgeon noted the 80 pound torque knob took very little pressure to move out.The rocker arm side had too much play and was loose.There was patient contact but no patient injury.There was no revision/medical intervention required.There was no surgery delay.Additional information was requested and on 01aug2016, the following was received from the customer: the product problem discovered at the point of use on the patient to undergo a craniotomy on (b)(6) 2016.The patient was already anesthetized when the problem occurred.The same a1059 was continued to be used.

Manufacturer Narrative

Integra completed its internal investigation 09/19/2016.The investigation included: method: -device history review.-integra complaint management database was reviewed for similar complaints.-evaluation of product.Results: a dhr review of lot code 137 shows that the following lots passed all necessary inspection points with no mrr, reworks or variances.No service history on file for this returned device.A two year look back in complaint management system for this reported failure and or related to ¿ratchet extension is stiff and does not move smoothly" for this product id shows that 6 complaints were received including this case.No new design or manufacturing trends have been identified.The returned unit it has passed all specific functional testing requirements, except for the lock having rotational movement, when unit is properly positioned and put under pressure unit will function properly.The rocker arm is tight from a residue build up.The 80# torque knob passed pressure test.General maintenance and cleaning required.Conclusion: in summary, the end users reason for return was partially confirmed as the stiffness encountered was due to residue buildup.The 80 # torque knob passed all required testing.As for the play or looseness with the rocker arm, this movement was observed however, when this device is properly positioned and placed under pressure this device would function properly.General maintenance required as this device was manufactured in 2013 with no prior service history.

Manufacturer Narrative

Additional information was received on 31 oct 2016: the patient's age and gender and date of the incident were not identified.The product problem was discovered during the positioning of the patient and the patient was already anesthetized.The type of surgery being performed was a craniotomy.A replacement device was available for use and the mayfield modified skull clamp was returned for evaluation.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5847848
• MDR Text Key: 52415012
• Report Number: 3004608878-2016-00207
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2013
• 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