MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINE CLAMP FOR SPINE NAVIGATION PACKAGE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	6002-016-000
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was undoing the clamp to clamp onto the patients spine when the end of the clamp broke off.Surgeon then used the other clamp in the navigation set.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
Event or Problem Description
It was reported that the surgeon was undoing the clamp to clamp onto the patients spine when the end of the clamp broke off.Surgeon then used the other clamp in the navigation set.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: SPINE CLAMP FOR SPINE NAVIGATION PACKAGE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9139973
• Report Number: 0001811755-2019-03139
• Device Sequence Number: 19617255
• Product Code: HAW
• UDI-Device Identifier: 04546540350206
• UDI-Public: 04546540350206
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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: 6002-016-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1