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

Catalog Number A1059

Device Problems Material Separation (1562); Difficult to Open or Close (2921); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during a case, a ratchet arm was very difficult to close.When the surgeon was readjusting the clamp, it pulled apart without having to pull the plunger to disengage the clamp.The clamp was swapped out.No injury to patient reported.No death alleged and there was no surgical delay reported.The clamp has been pulled from service additional request for information has been sent.

Manufacturer Narrative

Investigation completed 07/17/2017.Device history record reviewed for sn (b)4) work order 2001041 lot/ 174 manufactured on 3/23/2017 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points except for rejected product labels which were replaced.Previous service history: (b)(4) repair of damaged starburst teeth.No manufacturing or design related trend has been identified.Root cause could not be determined at this time.The unit was set up and tested and passed all items except that the ratchet area had drag as it passes through the base.However, this failure item is not related to the complaint issue.The lock has rotational movement, but when unit is properly positioned and put under pressure, unit will function properly.Repair cannot duplicate the ratchet extension arm not holding in place.Unit needs heli-coils added to large starburst threads to eliminate rotational movement.General maintenance and cleaning required.

• 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: annette orlando ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6640972
• MDR Text Key: 77840659
• Report Number: 3004608878-2017-00187
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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