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

Model Number	48280310
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem 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 second of two es2 polyaxial screwdrivers.
Additional Manufacturer Narrative
H3 other text : device location unknown.
Event or Problem 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 second of two es2 polyaxial screwdrivers.
Additional Manufacturer Narrative
H6 coding has been updated to reflect investigation conclusion.

• Brand Name: ES2 POLYAXIAL SCREWDRIVER
• Common Device Name: 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: 17070711
• Report Number: 0009617544-2023-00043
• Device Sequence Number: 12294534
• Product Code: NKB
• UDI-Device Identifier: 04546540710475
• UDI-Public: 04546540710475
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown