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

Model Number 80-1531

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

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

Event Date 03/30/2017

Event Type  malfunction  

Event Description

Surgeon was using the malis right angle ball tip nerve hook and the ball tip broke off during c5-7 anterior cervical discectomy fusion.

• Brand Name: MALIS
• Type of Device: HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SYMMETRY SURGICAL INC.; 3034 owen dr.; antioch TN 37013
• MDR Report Key: 6546018
• MDR Text Key: 74487270
• Report Number: 6546018
• 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: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 80-1531
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2017
• 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 Outcome(s): Other
• Patient Age: 49 YR