MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PHOTONGUIDE, NARROW/FLAT; LIGHT, SURGICAL, FIBEROPTIC

Model Number	Narrow / Flat
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discarded at account.
Event or Problem Description
It was reported that during a surgical procedure at the user facility, the device broke in half.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.

• Brand Name: PHOTONGUIDE, NARROW/FLAT
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9907819
• Report Number: 0001811755-2020-00843
• Device Sequence Number: 2718301
• Product Code: FST
• UDI-Device Identifier: 00816728021650
• UDI-Public: 00816728021650
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

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: Health Professional
• Device Model Number: Narrow / Flat
• Device Catalogue Number: 104008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1