MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (20 X 1.27 X 105MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6720127105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device evaluated by manufacturer? awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke.It was also reported that the broken piece was retrieved from the patient.It was further reported that a delay of 5 minutes occurred due to 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
H6; the reported event, for blade break, was not confirmed as the blade was not returned for evaluation.Without the blade, the root cause cannot be determined.H3 other text : device not available for return.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke.It was also reported that the broken piece was retrieved from the patient.It was further reported that a delay of 5 minutes occurred due to this event.It was also reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• Brand Name: PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (20 X 1.27 X 105MM)
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10373850
• Report Number: 0001811755-2020-02083
• Device Sequence Number: 3001699
• Product Code: HWE
• UDI-Device Identifier: 07613327143737
• UDI-Public: 07613327143737
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020

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: 6720127105
• Device Catalogue Number: 6720127105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1