MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP THORACIC PEDICLE FEELER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6002-350-000
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the service evaluation process conducted at the manufacturer facility it was observed that the tip of the device was loose which can lead to inaccuracies.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
During the service evaluation process conducted at the manufacturer facility it was observed that the tip of the device was loose which can lead to inaccuracies.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the manufacturer facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: THORACIC PEDICLE FEELER
• 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: 17377716
• Report Number: 3015967359-2023-01485
• Device Sequence Number: 6384202
• Product Code: HAW
• UDI-Device Identifier: 04546540503824
• UDI-Public: 04546540503824
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K012380
• 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): 11/03/2023

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 Catalogue Number: 6002-350-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown