MAUDE Adverse Event Report: SYMMETRY SURGICAL, INC. MALIS NERVE HOOK; HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number GERMANY 096

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 05/31/2016

Event Type  malfunction  

Event Description

Tip of nerve hook broke off during surgery.Tip of nerve hook was found in the drapes prior to the end of the procedure.

• Brand Name: MALIS NERVE HOOK
• Type of Device: HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SYMMETRY SURGICAL, INC.; 3034 owen drive; antioch TN 37013
• MDR Report Key: 6056863
• MDR Text Key: 58381200
• Report Number: 6056863
• Device Sequence Number: 1
• Product Code: GDG
• 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: 06/24/2016,09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GERMANY 096
• Device Catalogue Number: 80-1532
• Other Device ID Number: 81 CE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR