ACCUFEX 3.5MM(L196) 7207098

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-04-04 for ACCUFEX 3.5MM(L196) 7207098 manufactured by Smith & Nephew Endoscopy.

Event Text Entries

[48608] During mosaic cartilage transplant of left knee, 3. 5mm chisel broke & portion lodged in pt's knee (patella).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 82828
• MDR Report Key: 82828
• Date Received: 1997-04-04
• Date of Report: 1997-03-06
• Date of Event: 1997-03-06
• Date Facility Aware: 1997-03-06
• Report Date: 1997-03-06
• Date Reported to Mfgr: 1997-03-07
• Date Added to Maude: 1997-04-14
• 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
• 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: ACCUFEX
• Generic Name: TUBULAR CHISEL
• Product Code: KDG
• Date Received: 1997-04-04
• Model Number: 3.5MM(L196)
• Catalog Number: 7207098
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 82203
• Manufacturer: SMITH & NEPHEW ENDOSCOPY
• Manufacturer Address: * MANSFIELD MA 02048 US
• Baseline Brand Name: ACUFEX MOSAICPLASTY TUBULAR CHISEL 3.5MM
• Baseline Generic Name: BONE CHISEL
• Baseline Model No: NA
• Baseline Catalog No: 7207098
• Baseline ID: LOT NUMBER 196
• Baseline Device Family: MOSAICPLASTY
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K962789
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-04-04