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

Model Number 6002-350-000

Device Problems Incorrect Measurement (1383); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2022

Event Type  malfunction  

Event Description

Per the customer, the metal probe is loose, causing instability and inaccuracy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

Event Description

Per the customer, the metal probe is loose, causing instability and inaccuracy.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

Manufacturer Narrative

Update: d9, h3, h6.Device evaluation: follow-up report submitted to document the device evaluation.

• Brand Name: THORACIC PEDICLE FEELER
• Type of Device: 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: 16085207
• MDR Text Key: 308354477
• Report Number: 3015967359-2023-00002
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04546540503824
• UDI-Public: 04546540503824
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• 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
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1