MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP MICRO DUAL CUT (13.0 X 0.38 X 39.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	5400003108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a femoral osteotomy procedure, the blade broke at the teeth.It was also reported that fragments of the broken blade were left in the patient, the family was consulted and did not choose to have a revision surgery/fragments removed at this time.It was further reported that there was no medical intervention and no delays as a result of this event, and that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Additional Manufacturer Narrative
H2: device evaluation.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during a femoral osteotomy procedure, the blade broke at the teeth.It was also reported that fragments of the broken blade were left in the patient, the family was consulted and did not choose to have a revision surgery/fragments removed at this time.It was further reported that there was no medical intervention and no delays as a result of this event, and that the procedure was completed successfully.

• Brand Name: MICRO DUAL CUT (13.0 X 0.38 X 39.0MM)
• 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: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 20677410
• Report Number: 3015967359-2024-02325
• Device Sequence Number: 8305001
• Product Code: GFA
• UDI-Device Identifier: 04546540401809
• UDI-Public: (01)04546540401809(17)280901(10)23236017
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Catalogue Number: 5400003108
• Device Lot Number: 23236017
• 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: 10/29/2024
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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