MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 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	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a femoral and tibial osteotomy procedure, the blade broke.No further information was provided at this time.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available for return.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.
Event or Problem Description
It was reported that during a femoral and tibial osteotomy procedure, the blade broke.It was subsequently reported that the saw blade was stuck inside the patient's bone and was successfully retrieved with no adverse consequences.It was further reported that there was a ten minute delay as a result of this event.
Event or Problem Description
It was reported that during a femoral and tibial osteotomy procedure, the blade broke.It was subsequently reported that the saw blade was stuck inside the patient's bone and was successfully retrieved with no adverse consequences.It was further reported that there was a ten minute delay as a result of this event.
Additional Manufacturer Narrative
B5: updated based on new information.

• 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-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: 15968040
• Report Number: 3015967359-2022-02438
• Device Sequence Number: 14729343
• Product Code: HWE
• UDI-Device Identifier: 07613327143737
• UDI-Public: 07613327143737
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 01/05/2023; 01/11/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/05/2023; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown