MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP

Catalog Number A3059

Device Problems Electrical /Electronic Property Problem (1198); Material Separation (1562)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that when manually manipulating the torque knob, the washer and nut came loose.There was no pt contact.There was no pr prepped for surgery nor was there any surgery delay.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2015.The investigation included: evaluation of actual device.Review of device history records.Review of complaints history.Results: device history record reviewed for this product id serial # (b)(4) manufactured on march 12, 2015 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 on file for this device.A two year lookback in trackwise for this reported failure and or related to " torque knob washer and nut came loose" for this product id shows that 5 complaints were received including this case.No new design or manufacturing trends have been identified.Conclusion: the complaint device noted in this report (pr130003) likely failed as a result of being subjected to a traumatic event, significant enough to not only cause the torque screw to disassemble, but also cause the piston to bend approximately.020¿ (.040¿ tir) {causes unknown at this time}.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: COMPOSITE SERIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4865064
• MDR Text Key: 21843408
• Report Number: 3004608878-2015-00174
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• 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