MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6425127105
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
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 preparation for a total knee arthroplasty surgical procedure, the blade broke at the mount.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported, that during preparation for a total knee arthroplasty surgical procedure.The blade broke at the mount.It was also reported, there were no delays and no adverse consequences as a result of this event.It was further reported, that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: STRYKER PRECISION OSCILLATING TIP SAW CARTRIDGE (25X1.27X105MM)
• 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: 12780292
• Report Number: 3015967359-2021-02534
• Device Sequence Number: 5942683
• Product Code: HWE
• UDI-Device Identifier: 07613327143744
• UDI-Public: 07613327143744
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/23/2021

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 Expiration Date: 06/01/2026
• Device Model Number: 6425127105
• Device Catalogue Number: 6425127105
• Device Lot Number: 21154027
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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