MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.37 X 105MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	6725137105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return.A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a total knee arthroplasty that two precision blades broke at the contact point of the precision saw.It was further reported that there was a short delay to get a new blade.It was also reported that there were no adverse consequences and that the procedure was completed successfully.This report is for the second blade that broke.
Additional Manufacturer Narrative
H3 & h6 investigation results indicate that the most probable root cause of the cartridge break is as a result of issues with the handpiece (b)(6).The td ost shaft broke between the link and the bottom bearing in the associated handpiece.The quality investigation is complete.
Event or Problem Description
It was reported that during a total knee arthroplasty that two precision blades broke at the contact point of the precision saw.It was further reported that there was a short delay to get a new blade.It was also reported that there were no adverse consequences and that the procedure was completed successfully.This report is for the second blade that broke.

• Brand Name: PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (25 X 1.37 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: 8176000
• Report Number: 0001811755-2018-02830
• Device Sequence Number: 2016026
• Product Code: HWE
• UDI-Device Identifier: 07613327143775
• UDI-Public: 07613327143775
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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 Expiration Date: 08/01/2023
• Device Catalogue Number: 6725137105
• Device Lot Number: 18232017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1