MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (20X1.27X90MM); INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	6720127090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Device not available for return to manufacturer.
Event or Problem Description
It was reported that the surgeon observed postoperatively during tourniquet removal that the patients popliteal artery was cut during a knee replacement surgery.It was also reported that the patient underwent vascular surgery to repair the artery.
Additional Manufacturer Narrative
The device was not returned for investigation.The quality investigation is complete.
Event or Problem Description
It was reported that the surgeon observed postoperatively during tourniquet removal that the patients popliteal artery was cut during a knee replacement surgery.It was also reported that the patient underwent vascular surgery to repair the artery.

• Brand Name: PRECISION FALCON OSCILLATING TIP SAW CARTRIDGE (20X1.27X90MM)
• 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: 8453340
• Report Number: 0001811755-2019-00944
• Device Sequence Number: 198584
• Product Code: HWE
• UDI-Device Identifier: 07613327143768
• UDI-Public: 07613327143768
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/04/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6720127090
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8209000000
• Outcome Attributed to Adverse Event: Required Intervention