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

Catalog Number A1059

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2017

Event Type  malfunction  

Event Description

Surgeon had a patient in the clamp at 60lbs pressure and the head was rocking.Patient was in surgery for craniotomy.Age and gender unknown.There was a delay for approx.10-15mins while the skull clamp was changed.Surgery was completed with another skull clamp.No adverse event or injury to patient.

Manufacturer Narrative

Investigation completed 03/16/2017.Method: dhr review, trend analysis, failure analysis.Device history record reviewed for this product id lot # 127 manufactured on august 31, 2012 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated variances.A two year lookback in complaint management system for this reported failure and/or related to "movement/rocking" for this product id shows that 6 complaints were received including this case.No new design or manufacturing trends have been identified.This issue will be monitored.Service notes: device has been cleaned and inspected.Index knob requires re-tensioning.Recommend unit undergo general service including full disassembly, cleaning and replacement of minor parts in order to restore full function to manufacturer¿s specifications.In addition, the service technician has commented that the device showed signs of prolonged use without service/maintenance being done.Conclusion: in summary, the end users reason for return was verified.The most likely cause could be normal wear.General maintenance is required as this device is believed to be manufactured in 2012 with no service history on file.

• 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: 6330409
• MDR Text Key: 67661127
• Report Number: 3004608878-2017-00042
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: G1647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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