MAUDE Adverse Event Report: STRYKER CORP. PRECISION FALCON; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 6725-127-105

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2017

Event Type  malfunction  

Event Description

Surgeon was using the stryker oscillating tip saw cartridge during a total hip procedure.The tip broke off but was retrieved by the surgeon - it was not retained in the patient.

• Brand Name: PRECISION FALCON
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER CORP.; 5900 optical ct; san jose CA 95138
• MDR Report Key: 6773372
• MDR Text Key: 82031015
• Report Number: 6773372
• Device Sequence Number: 0
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2022
• Device Model Number: 6725-127-105
• Device Lot Number: 17062017
• Other Device ID Number: 1380148
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR