MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SHARP KERRISON; RONGEUR HANDLE

Model Number 53-1675

Device Problem Break (1069)

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

Event Date 07/23/2018

Event Type  malfunction  

Event Description

Piece of instrument broke while instrument was in use during surgery.

• Brand Name: SYMMETRY SHARP KERRISON
• Type of Device: RONGEUR HANDLE
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: victoria rogers ; 3034 owen drive; antioch, TN 37013 ; 8002513000
• MDR Report Key: 7811569
• MDR Text Key: 118393812
• Report Number: 3007208013-2018-00017
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K130541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 53-1675
• Device Catalogue Number: 53-1675
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1