MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO POINTER, KNEE NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6003-011-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tip of the device was observed to be broken prior to re-processing; this poses the risk of a small component being lost in the surgical site.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
The customer reported that the tip of the device was observed to be broken prior to re-processing; this poses the risk of a small component being lost in the surgical site.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.

• Brand Name: POINTER, KNEE NAVIGATION
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8949769
• Report Number: 0001811755-2019-02876
• Device Sequence Number: 16808634
• Product Code: HAW
• UDI-Device Identifier: 04546540246028
• UDI-Public: 04546540246028
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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 Catalogue Number: 6003-011-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1