MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP COUPLING FOR ORTHOPEDIC ANCHORING SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6007-003-000
Medical Device Problem Codes	Incorrect Measurement (1383); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, licensing for the automated functionality portion of the q guidance system was not loaded correctly.The customer instead used the non-automated software package available with the q guidance system.While placing a hip pin, movement was shown on the screen without moving the device.Two of the eight screws were shown medial after following the planned projection.Per the customer, it appeared the screws shifted.Per additional clarification, the ortholock pin system was used during the procedure, however; only two of the three screws were used to fixate the ortholock on the patient's anatomy, which can lead to inaccuracy.Additional information has been requested from the user facility.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
Per the customer, licensing for the automated functionality portion of the q guidance system was not loaded correctly.The customer instead used the non-automated software package available with the q guidance system.While placing a hip pin, movement was shown on the screen without moving the device.Two of the eight screws were shown medial after following the planned projection.Per the customer, it appeared the screws shifted.Per additional clarification, the ortholock pin system was used during the procedure, however; only two of the three screws were used to fixate the ortholock on the patient's anatomy, which can lead to inaccuracy.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.

• Brand Name: COUPLING FOR ORTHOPEDIC ANCHORING SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16356317
• Report Number: 3015967359-2023-00396
• Device Sequence Number: 6261299
• Product Code: HAW
• UDI-Device Identifier: 04546540442895
• UDI-Public: 04546540442895
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K993239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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
• Device Model Number: 6007-003-000
• Device Catalogue Number: 6007-003-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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