MAUDE Adverse Event Report: WIGGINS MEDICAL WIGGINS MEDICAL; CASPER FENESTRATED PITUITARY RONGEUR

Model Number 52-097-20B

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 04/10/2015

Event Type  Injury  

Event Description

Jaw of upbiting casper fenestrated pituitary rongeurs broke during normal use of instrument.Instrument being used during lumbar laminotomy, foraminotomy, and discectomy l5-s1.All pieces retrieved from incision.

• Brand Name: WIGGINS MEDICAL
• Type of Device: CASPER FENESTRATED PITUITARY RONGEUR
• Manufacturer (Section D): WIGGINS MEDICAL; tallehassee FL 32308
• MDR Report Key: 4714062
• MDR Text Key: 16850272
• Report Number: MW5042180
• Device Sequence Number: 1
• Product Code: HTX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 52-097-20B
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 92