MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.27 X 105MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6725127105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a total knee arthroplasty procedure, the blade started to smoke and broke at the tip.An x-ray was performed to make sure all metal shads had been removed from the bone.A surgical delay of 20 mins was reported.It was also reported that there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Additional Manufacturer Narrative
The quality investigation is complete.
Event or Problem Description
It was reported that during a total knee arthroplasty procedure, the blade started to smoke and broke at the tip.An x-ray was performed to make sure all metal shads had been removed from the bone.A surgical delay of 20 mins was reported.It was also reported that there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.27 X 105MM)
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 15536978
• Report Number: 3015967359-2022-01849
• Device Sequence Number: 15196582
• Product Code: HWE
• UDI-Device Identifier: 07613327143720
• UDI-Public: 07613327143720
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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): 12/06/2022

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: 6725127105
• Device Catalogue Number: 6725127105
• Device Lot Number: 22087017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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