* BALL TIP MICRO NERVE HOOK TIP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-30 for * BALL TIP MICRO NERVE HOOK TIP manufactured by Codman & Shurtleff, Inc..

Event Text Entries

[1788090] Ball tip micro nerve hook's tip broke off in patient while being used by doctor during procedure. Tip was retrieved by doctor. Per doctor, all pieces of instrument were removed from the patient and patient did not sustain any injury from the instrument breaking.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1951412
• MDR Report Key: 1951412
• Date Received: 2010-12-30
• Date of Report: 2010-12-30
• Date of Event: 2010-12-01
• Report Date: 2010-12-30
• Date Reported to FDA: 2010-12-30
• Date Added to Maude: 2011-01-06
• 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: *
• Generic Name: INSTRUMENT, MICROSURGICAL
• Product Code: GZX
• Date Received: 2010-12-30
• Model Number: BALL TIP MICRO NERVE HOOK TIP
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 18 MO
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CODMAN & SHURTLEFF, INC.
• Manufacturer Address: 325 PARAMOUNT DR RAYNHAM MA 02767035 US 02767 0350

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-12-30