MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA FASTSYSTEM STERILE FIELD POST; SURGICAL RETRACTOR

Catalog Number 4080

Device Problems Component or Accessory Incompatibility (2897); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer reports system lost strength and blades were curved.No patient harm.No further information available.

Manufacturer Narrative

On 7/25/2017 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - evaluation was unable to conclusively verify customer complaint.The sterile field post got manipulated by untrained personal.The table fixation bolt and threads got messed up by welding nuts to the post.The whole field post need to get replaced and charged to the customer.Device history evaluation - is - a device modified by end user; is not - a suspected manufacturing defect; is- misuse by customer.Dhr could not be reviewed as device not marked with lot number.The most likely reason for no lot marking is device was manufactured in (b)(4) prior to 2003 which is prior to requirement for lot traceability.Conclusion: failure analysis to identify root cause determined device modified \ damaged by end user.

• Brand Name: FASTSYSTEM STERILE FIELD POST
• Type of Device: SURGICAL RETRACTOR
• 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: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6705806
• MDR Text Key: 79782545
• Report Number: 2125289-2017-00008
• Device Sequence Number: 1
• Product Code: FFO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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