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

Catalog Number	6003-012-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the tip broke off posing the risk of a small component being lost in the surgical site.Although requested, no information was available regarding how the reported event was noticed or if the procedure was completed successfully.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported that the tip broke off posing the risk of a small component being lost in the surgical site.Although requested, no information was available regarding how the reported event was noticed or if the procedure was completed successfully.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• 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: 8687841
• Report Number: 0001811755-2019-01966
• Device Sequence Number: 11317815
• Product Code: HAW
• UDI-Device Identifier: 04546540470331
• UDI-Public: 04546540470331
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 6003-012-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1