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

Catalog Number A1059

Device Problems Failure To Service (1563); Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/09/2017

Event Type  malfunction  

Event Description

It was reported that the rocker arm had play/movement when clamped.Additional information has been requested.

Manufacturer Narrative

Investigation completed 5/22/2017.Method: device history review: trend analysis, failure analysis.Device history record reviewed for lot/ 094 manufactured on 1/22/2010.The dhr on both the assembly and subassembly level 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 look back from 04/19/2015 to 04/19/2017 for this reported failure using key words "rocker arm, play, movement " for product id a1059 shows that 2 complaints were received including this case.No new design or manufacturing trends have been identified.Unit received with the lock having both rotational and lateral movement and a residue buildup is present.Upon disassembly, repair noted the index knob is cracked and the lock will need new components added to replace worn internal parts.Unit needs to be machined to have heli-coils added to large starburst threads.The rocker arm failed the go no-go gage and will need to be replaced.The set screw in the swivel base was tight; general maintenance and cleaning required.Conclusion: the root cause for this failure is the unit has a cracked index knob and damaged threads inside the starburst area, causing excess play and movement in the unit.

• 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: 6559922
• MDR Text Key: 75104556
• Report Number: 3004608878-2017-00151
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• 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: 094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2010
• 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