MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 6.5X40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482802640

Device Problem Difficult to Remove (1528)

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

Event Date 01/04/2016

Event Type  malfunction  

Event Description

It was reported that during the surgery, surgeon inserted k-wire to the vertebral body.After inserting a screw, the surgeon tried to pull out k-wire, but it was not possible to pull it out.Therefore, the surgeon removed the k-wire along with the screw, and used a brand-new k-wire and brand-new screw.

Manufacturer Narrative

Lot#: 157520.Visual inspection; device history review; complaint history review; risk assessment the returned was confirmed to be jammed upon visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.The plausible root cause of the reported is not determined and/or multifactorial.

Event Description

It was reported that during the surgery, surgeon inserted k-wire to the vertebral body.After inserting a screw, the surgeon tried to pull out k-wire, but it was not possible to pull it out.Therefore, the surgeon removed the k-wire along with the screw, and used a brand-new k-wire and brand-new screw.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X40MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rakshya bista ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5393700
• MDR Text Key: 37007656
• Report Number: 0009617544-2016-00026
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 482802640
• Device Lot Number: 157520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1