MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number A2114

Device Problems Break (1069); Sticking (1597)

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

Event Date 04/27/2017

Event Type  malfunction  

Event Description

Skull clamp broke in half while on the patient¿s head for an aneurysm case.The screw broke that was attached to the clamp with the transition arm.The screw that attaches the bed attachment to the mayfield head holder for the radiolucent set snapped during the surgery.The customer could not use a new bed attachment because half of the screw was stuck in the head holder, so they stapled the patient's head closed, undraped, unpinned, and placed a new head holder and new bed attachment.The patient was fine and surgery was completed.The customer stated the system was set up appropriately and all joints fully tight.The only thing the customer was not aware of is whether over tightening may lead to chronic stress of the joints and screws.It was reported that the screw was placed on the inner/caudal side of the mayfield head holder rather than the outer/rostral side.The customer stated they do that all the time with the metal head holders.Additional information has been requested.

Manufacturer Narrative

Investigation completed 6/22/2017.Method: device history review/service history.Trend analysis.Failure analysis.Device history record reviewed for product id a2114, serial # (b)(4) was manufactured on 12mar13 with 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.There is no service history for this device.A two year look back from 06/02/2015 to 06/02/2017 for this reported failure and or related to "broke " for this product id a2114 shows that 4 complaints were received including this case, see below.No new design or manufacturing trends have been identified.Complaint was not confirmed for the skull clamp as the thread shaft from the adapter was fractured off in the threaded hole of the skull clamp.Also noted the 80# torque knob was received apart and is missing the retaining ring and 1 internal washer.Conclusion: the complaint was not confirmed for this device (skull clamp) but was confirmed for the adapter that was attached to the skull clamp.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• 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: 6574873
• MDR Text Key: 75613544
• Report Number: 3004608878-2017-00161
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K090506
• 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
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2013
• 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