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

Catalog Number	6007-011-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During the service evaluation process conducted at the manufacturer facility it was observed that the tip was broken off; this poses the risk of a small component being lost in the surgical site.As this event occurred during service evaluation at the manufacturer facility, there was no medical intervention, adverse consequences, patient involvement and/or delay to a surgical procedure were reported with this event.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
During the service evaluation process conducted at the manufacturer facility it was observed that the tip was broken off; this poses the risk of a small component being lost in the surgical site.As this event occurred during service evaluation at the manufacturer facility, there was no medical intervention, adverse consequences, patient involvement and/or delay to a surgical procedure were reported with this event.

• Brand Name: POINTER, STRAIGHT
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8627790
• Report Number: 0001811755-2019-01764
• Device Sequence Number: 11288502
• Product Code: HAW
• UDI-Device Identifier: 04546540392114
• UDI-Public: 04546540392114
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 6007-011-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1