MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION FALCON 90.0MM OSCILLATING TIP SAW CARTRIDGE (25X1.33X90MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	6625127090
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during an orthopedic procedure, while cutting the femur, the blade broke.It was also reported that the (b)(6) was bending and flexing the blade when entering the cutting block, there was contact with the cutting guide.It was further reported that there was a ten minute delay as a result of this event.It was also reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Event or Problem Description
It was reported that during an orthopedic procedure, while cutting the femur, the blade broke.It was also reported that the surgeon was bending and flexing the blade when entering the cutting block, there was contact with the cutting guide.It was further reported that there was a ten minute delay as a result of this event.It was also reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.

• Brand Name: PRECISION FALCON 90.0MM OSCILLATING TIP SAW CARTRIDGE (25X1.33X90MM)
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9136067
• Report Number: 0001811755-2019-03109
• Device Sequence Number: 2929015
• Product Code: GFA
• UDI-Device Identifier: 04546540684349
• UDI-Public: 04546540684349
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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): 11/21/2019

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: 6625127090
• Device Catalogue Number: 6625127090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1