MAUDE Adverse Event Report: INTEGRA YORK, PA INC. STERILE FIELD POST, 1/2; SURGICAL RETRACTOR

Catalog Number 10708

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

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 initially reports that the two omni field posts can rotate left and right at the clamp after being locked into position (while holding the 4020 support arm.On (b)(6) 2016 customer reports an anterior lumbar interbody fusion was being performed.The issue occurred as soon as they started using the device.This is not first time use for this device.No further information available.

Manufacturer Narrative

On 12/1/16 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - both units received have rough threads on the post bolt that will need to be retapped.Both units also have bent handles on the post clamp subassemblies allowing the clamps to rotate when in the locked position.General maintenance needed.Device history evaluation - device history record reviewed for this product id show no abnormalities related to the reported failure.Passed all required inspection points with no associated mrr¿s, variances or rework.No service history is on file for this device.Conclusion: in summary the end users reason for return was verified.

• Brand Name: STERILE FIELD POST, 1/2
• Type of Device: SURGICAL RETRACTOR
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6086530
• MDR Text Key: 59415286
• Report Number: 2125289-2016-00010
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• 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