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

Catalog Number A1114A

Device Problems Device Operates Differently Than Expected (2913); Mechanics Altered (2984)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2016

Event Type  malfunction  

Event Description

This is the second of two reports (second skull clamp).The rocker arm lock was in a state of disrepair rendering the equipment unpredictable, difficult to use and unsuitable for surgery.The device was not in contact with a patient.There was no patient injury.Patient was prepped for surgery.Surgery delay was reported to be 10 minutes.They used a second clamp but it had the same issue.The had to go to a third clamp.Additional information was requested and on 11jul2016, the following was provided by the customer: the skull clamp did not come into contact with a patient prior to its most recent return to integra.When the skull clamp was received back from its last repair, it was tested and the locking mechanism was found to be still be faulty.Linked to mfg.Report number: 3004608878-2016-00188.

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.-review of complaint history.Results: evaluation of device: the swivel base retainer screw became loose.This device was manufactured on december 31, 2009.Service history: date of service: 2/2/2016.A two year lookback in complaint system for this reported failure and or related to " experiencing issues with rotational movement" for this product family shows that 5 complaints were received including this case.In summary the end users reason for return was verified however the root cause can not be determined at this time.An in-service is being recommended to ensure customer satisfaction and this issue is currently being monitored.

• Brand Name: STANDARD INFINITY 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: 5800590
• MDR Text Key: 50528793
• Report Number: 3004608878-2016-00189
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2009
• 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