MAUDE Adverse Event Report: STRYKER; BLADE, SAW

Model Number 2108109000S10

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)

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

Event Date 08/25/2015

Event Type  malfunction  

Event Description

One of the teeth on the saw blade snapped off.I noticed the missing tooth as we were closing the incision.

• Type of Device: BLADE, SAW
• Manufacturer (Section D): STRYKER; 2825 airview blvd.; portage MI 49002
• MDR Report Key: 5123675
• MDR Text Key: 27374092
• Report Number: 5123675
• Device Sequence Number: 1
• Product Code: GFA
• 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
• Report Date: 08/31/2015,09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2108109000S10
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 114