MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO THORACIC PEDICLE FEELER

Model Number	6002-350-000
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility, the instrument broke at the tip while in the patient¿s bone.The tip was successfully removed during the same procedure with no difficulties.There were no reported adverse consequences, no significant procedure delays and there was no medical intervention required.
Event or Problem Description
It was reported that during a procedure at the user facility, the instrument broke at the tip while in the patient¿s bone.The tip was successfully removed during the same procedure with no difficulties.There were no reported adverse consequences, no significant procedure delays and there was no medical intervention required.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: THORACIC PEDICLE FEELER
• Common Device Name: THORACIC PEDICLE FEELER
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8800158
• Report Number: 0001811755-2019-02281
• Device Sequence Number: 18897732
• Product Code: HAW
• UDI-Device Identifier: 04546540503824
• UDI-Public: 04546540503824
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: No Information
• Device Model Number: 6002-350-000
• Device Catalogue Number: 6002-350-000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1