MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHO GRIP KNEE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	6003-012-000
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	09/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the device was broken; 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 the device was discarded by the customer, no evaluation is possible.Discarded by user.
Event or Problem Description
It was reported that the tip of the device was broken; 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: ORTHO GRIP KNEE POINTER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9167055
• Report Number: 0001811755-2019-03191
• Device Sequence Number: 19804422
• Product Code: HAW
• UDI-Device Identifier: 04546540470331
• UDI-Public: 04546540470331
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 03/20/2020

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: 6003-012-000
• Device Catalogue Number: 6003-012-000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1