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

Model Number	6002-350-000
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer, the tip of a thoracic pedicle feeler broke off inside the patient and was unable to be removed.The device fractured at the patient's sacroiliac joint during a revision surgery of an iliac bolt that had been previously placed in the patient.Per the clinical specialist observing the case, the thoracic pedicle feeler was positioned directly next to the iliac bolt.While attempting to create a pilot hole for the thoracic pedicle feeler, the iliac bolt was struck, the gear shaft bent and the tip broke off as well as the handle.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
Per the customer, the tip of a thoracic pedicle feeler broke off inside the patient and was unable to be removed.The device fractured at the patient's sacroiliac joint during a revision surgery of an iliac bolt that had been previously placed in the patient.Per the clinical specialist observing the case, the thoracic pedicle feeler was positioned directly next to the iliac bolt.While attempting to create a pilot hole for the thoracic pedicle feeler, the iliac bolt was struck, the gear shaft bent and the tip broke off as well as the handle.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• 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: 15076327
• Report Number: 3015967359-2022-01329
• Device Sequence Number: 5338887
• Product Code: HAW
• UDI-Device Identifier: 04546540503824
• UDI-Public: 04546540503824
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 09/20/2022

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: 6002-350-000
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/20/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown