MAUDE Adverse Event Report: BD/V. MEULLER V. MEULLER; INSTRUMENT, MICROSURGICAL

Catalog Number 3763.10

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

Small piece of metal ball tip from micro neuro nerve hook broke during surgery.

• Brand Name: V. MEULLER
• Type of Device: INSTRUMENT, MICROSURGICAL
• Manufacturer (Section D): BD/V. MEULLER; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7185590
• MDR Text Key: 97124470
• Report Number: 7185590
• Device Sequence Number: 1
• Product Code: GZX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017,12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 3763.10
• Other Device ID Number: MICRO NERVE HOOK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 44 YR