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

Catalog Number 53-1675

Device Problem Break (1069)

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

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

The device is being returned for evaluation.A follow-up report will be submitted once we have received the device and conducted our investigation.The delay in the fda receiving this complaint was due to a change in "esignature" certificates.The report was originally sent on (b)(6) 2019.

Event Description

Two sharp kerrison handles broke at the lever during use.

• Brand Name: SYMMETRY SHARP KERRISON
• Type of Device: RONGEUR
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• Manufacturer (Section G): SYMMETRY SURGICAL; 3034 owen drive; antioch TN 37013
• Manufacturer Contact: brandi meath ; 3034 owen drive; antioch, TN 37013
• MDR Report Key: 8676111
• MDR Text Key: 147316074
• Report Number: 3007208013-2019-00004
• Device Sequence Number: 1
• Product Code: HAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1617444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 53-1675
• Device Lot Number: 1600651, 1500492
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1