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

Catalog Number A2114

Device Problems Break (1069); Sticking (1597); Unintended Movement (3026)

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

Event Date 11/22/2016

Event Type  malfunction  

Event Description

This is the first of two reports (same user facility, same product id, same incident date, same product problem).Linked to mfg report: 3004608878-2016-00353.On (b)(6) 2016, a patient was positioned in the a2114 mayfield infinity xr2 skull clamp and prepped for surgery.After the positioning was complete, the surgeon noticed movement in the patient's head.Further inspection revealed that the standard knob assembly had broken and a portion of the broken knob was stuck in the skull clamp.The xr2 system was removed and another patient stabilization system was used.There was no patient injury but the incident led to a 45 minute delay in surgery.

Manufacturer Narrative

Integra has completed their internal investigation on 01/12/2017.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: complaint confirmed, though failure occurred with 437a2409 assembly from 40a1079 base unit assy.Service notes: unit cleaned per protocol.With respect to the returned unit (a2114) it has passed all specific functional testing requirements, knob was broke off of the 437a2409 that was received with unit.Device history record reviewed for product id a2114 lot # xr150856 a total of (b)(4) were manufactured on 07/29/2015 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 service history is on file for this device.A two year lookback in trackwise for this reported failure and or related to "broke " for product id's a2600r and a2114 shows that 3 complaints were received including this case.No new design or manufacturing trends have been identified.This issue will be monitored.Conclusion: according to the technician the root cause is difficult to determine.We could not say why the screw is broken.Maybe it is normal wear and tear.

• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6187490
• MDR Text Key: 63192813
• Report Number: 3004608878-2016-00352
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• 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: 12/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• 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