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

Model Number	NARROW / FLAT
Medical Device Problem Codes	Fracture (1260); Overheating of Device (1437)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility, the product broke.The procedure was completed successfully without a clinically significant delay; there were no adverse consequences or medical intervention.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.H3 other text: discarded by user.
Event or Problem Description
It was reported that prior to a surgical procedure at the user facility, the product broke.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: 9928476
• Report Number: 0001811755-2020-00867
• Device Sequence Number: 2741755
• 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,Followup
• Report Date (Section B): 02/15/2021

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
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1