*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-15 for * manufactured by Arthrex, Inc..

Event Text Entries

[98240] Medical record reviewed 07/08/1998. Pt with pre-operative diagnosis of severe posterior cruciate ligament laxity: questionable posteriolateral instability. Per incident report, the femoral guide pin sheared off while drilling the right knee. No pt injury. Pt recovered well and was discharged to home on next day.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1014179
• MDR Report Key: 177688
• Date Received: 1998-07-15
• Date of Report: 1998-07-08
• Date of Event: 1998-06-25
• Date Added to Maude: 1998-07-20
• 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
• 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: *
• Generic Name: GUIDE PIN
• Product Code: HXY
• Date Received: 1998-07-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: AR 1297L
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 172777
• Manufacturer: ARTHREX, INC.
• Manufacturer Address: 2885 HORSESHOE DR. S. NAPLES FL 34104 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-07-15