MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRO DUAL CUT (16.5 X 0.38 X 34.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	5400003104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during the removal of the fibula flap (bone removal for mandibular reconstruction), a tooth on the cutting end of the blade broke.The tooth fragment was found and removed from the patient.It was also reported that a second blade was used and the tooth on the outer blade also broke, the surgeon washed the site, but is unsure if the fragment was removed.It was further reported that the surgeon touched the metal retractor with the two blades in the procedure.The procedure was completed successfully with a delay of twenty minutes; no adverse consequences or medical intervention were reported.This report is for the second blade that broke.
Additional Manufacturer Narrative
H6: the quality investigation is complete.
Event or Problem Description
It was reported that during the removal of the fibula flap (bone removal for mandibular reconstruction), a tooth on the cutting end of the blade broke.The tooth fragment was found and removed from the patient.It was also reported that a second blade was used and the tooth on the outer blade also broke, the surgeon washed the site, but is unsure if the fragment was removed.It was further reported that the surgeon touched the metal retractor with the two blades in the procedure.The procedure was completed successfully with a delay of twenty minutes; no adverse consequences or medical intervention were reported.This report is for the second blade that broke.

• Brand Name: MICRO DUAL CUT (16.5 X 0.38 X 34.5MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16590839
• Report Number: 3015967359-2023-00594
• Device Sequence Number: 14176276
• Product Code: GFA
• UDI-Device Identifier: 04546540401779
• UDI-Public: 04546540401779
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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: 5400003104
• Device Catalogue Number: 5400003104
• Device Lot Number: 22226017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown