MAUDE Adverse Event Report: STRYKER SPINE-US STRYKER KWIC NEEDLE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6002-070-000
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Field retained device.
Event or Problem Description
A company representative reported that two navigated kwic needles became stuck in a patient's pedicle intra-operatively and an orthopedic slap hammer was required to extract the kwic needles which were removed in one piece.The procedure was completed successfully with a ten minute surgical delay and no adverse consequence to the patient.This report captures the first of two kwic needles.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported that two navigated kwic needles became stuck in a patient's pedicle intra-operatively and an orthopedic slap hammer was required to extract the kwic needles which were removed in one piece.The procedure was completed successfully with a ten minute surgical delay and no adverse consequence to the patient.This report captures the first of two kwic needles.

• Brand Name: STRYKER KWIC NEEDLE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16839065
• Report Number: 0002530131-2023-00004
• Device Sequence Number: 15171053
• Product Code: HAW
• UDI-Device Identifier: 00808232001365
• UDI-Public: 00808232001365
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140868
• 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): 08/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: 6002-070-000
• Device Catalogue Number: 6002070000
• Device Lot Number: T2212002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown