MAUDE Adverse Event Report: STRYKER SPINE-US ES2 POLYAXIAL SCREWDRIVER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 48280310

Device Problem Residue After Decontamination (2325)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device location unknown.

Event Description

A company representative reported that a procedure was not able to be completed as planned due to residue found in the shafts of two es2 polyaxial screwdrivers.The patient was closed and prescribed antibiotics to treat any potential infection.The patient will be rescheduled for a future surgery.This report is for the first of two es2 polyaxial screwdrivers.

Event Description

A company representative reported that a procedure was not able to be completed as planned due to residue found in the shafts of two es2 polyaxial screwdrivers.The patient was closed and prescribed antibiotics to treat any potential infection.The patient will be rescheduled for a future surgery.This report is for the first of two es2 polyaxial screwdrivers.

• Brand Name: ES2 POLYAXIAL SCREWDRIVER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 17070710
• MDR Text Key: 316663708
• Report Number: 0009617544-2023-00042
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540710475
• UDI-Public: 04546540710475
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48280310
• Device Catalogue Number: 48280310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other