ZIMMER-HALL STERNUM SAW 5059-05 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-03-30 for ZIMMER-HALL STERNUM SAW 5059-05 * manufactured by Zimmer Hall Surgical.

Event Text Entries

[174922] Right ventricular laceration occurred during repeat sternotomy in a pt with a history of "mustard" procedure for transposition of the great arteries and hodgkin's lymphoma. She had acute cardiac failure requiring open chest massage, failure to wean from cardiopulmonary bypass and conversion to extracorporeal membrane oxygenation. Pt expired 1/27/99. (a "re-do" sternal saw was availabe, but not used. )
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 216810
• MDR Report Key: 216810
• Date Received: 1999-03-30
• Date of Report: 1999-03-29
• Date of Event: 1998-12-31
• Date Facility Aware: 1998-12-31
• Report Date: 1999-03-29
• Date Reported to FDA: 1999-03-29
• Date Reported to Mfgr: 1999-03-29
• Date Added to Maude: 1999-04-02
• Event Key: 0
• Report Source Code: User Facility 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: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZIMMER-HALL STERNUM SAW
• Generic Name: *
• Product Code: KFK
• Date Received: 1999-03-30
• Model Number: 5059-05
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 210311
• Manufacturer: ZIMMER HALL SURGICAL
• Manufacturer Address: 1170 MARK AVENUE CARPINTERIA CA 930132918 US
• Baseline Brand Name: HALL STERNUM SAW (PNEUMATIC)
• Baseline Generic Name: STERNUM SAW PNEUMATIC
• Baseline Model No: NA
• Baseline Catalog No: 00505900500
• Baseline ID: NA
• Baseline Device Family: NA
• Baseline Shelf Life Contained: N
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K801737
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1999-03-30