MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; N/A

Catalog Number A1059

Device Problems Out-Of-Box Failure (2311); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Presents a flaw in the cushion that covers the pin in the torque screw.There was no patient prepped for surgery and no revision/medical intervention required.Out of box failure reported.

Manufacturer Narrative

Integra has completed their internal investigation on 8/23/2016.The investigation included: methods: evaluation of actual device.Review of device history records.Results: evaluation of device: the skull clamp was received with the helicoil outside of the ratchet assembly.Device history record reviewed for this product id lot code/work order: 159/135911 manufactured on 12/03/15 show no abnormalities related to the reported failure.This device passed all required inspection points with no associated mrr¿s, variances or rework.No service history is on file for this device.In summary: the helicoil displacement issue reported on the returned devices was able to be confirmed by integra engineering and quality.Capa has been opened to investigate this failure.The skull clamp¿s ratchet extension has a detailed assembly instruction that outlines the process of installing the helicoil.The last step in the work instructions requires the operator to use a ¾-16 thread gage to verify fit.All products in question were subjected to these quality controls during manufacture.These will be monitored for trending.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: N/A
• 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: 5804200
• MDR Text Key: 50731046
• Report Number: 3004608878-2016-00191
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• 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: 159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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