SAW 2108 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-10 for SAW 2108 * manufactured by Stryker.

Event Text Entries

[20461956] The dr observed a suspicious image on an x-ray. The pt had a total knee procedure. A 1/4 inch piece of metal was remove from the knee. It was determined that this metal was definitely from a stryker screw blade. The same week on another pt hosp had a similar occurrence of the metal clip shearing off a stryker blade and falling into the operating site. The piece was removed. The hosp has switched to another blade for future procedures.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1020182
• MDR Report Key: 300951
• Date Received: 2000-10-10
• Date of Report: 2000-10-03
• Date of Event: 2000-09-19
• Date Added to Maude: 2000-10-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SAW
• Generic Name: SAW BLADE
• Product Code: DZH
• Date Received: 2000-10-10
• Model Number: 2108
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 291274
• Manufacturer: STRYKER
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-10-10