MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 7.5X35MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 482802735

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Date 04/09/2015

Event Type  malfunction  

Event Description

During surgery, k-wire could not be removed from screw after screw insertion to left side s1.Surgeon tried to remove it forcibly, it was removed together with the screw from patient bone.After that, the surgeon inserted longer screw to left side s1 and finished the surgery.

Manufacturer Narrative

Lot # 149977, catalog #: 482802735.Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the manufacturing records were reviewed and no anomalies were found.No new harms or hazards were found.The visual examination of the returned product revealed a k wire that could not be removed from the cannula.Conclusion: it was unknown if the screw was previously damaged prior to surgery so the root cause of the reported event is not determined and/or multifactorial.

Event Description

During surgery, k-wire could not be removed from screw after screw insertion to left side s1.Surgeon tried to remove it forcibly, it was removed together with the screw from patient bone.After that, the surgeon inserted longer screw to left side s1 and finished the surgery.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X35MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: linford leitch ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 4743318
• MDR Text Key: 16864693
• Report Number: 0009617544-2015-00194
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 482802735
• Device Lot Number: 149977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 05/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2014
• 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