MAUDE Adverse Event Report: SYMMETRY SURGICAL INC SYMMETRY SURGICAL; KLEPPINGER TYPE PADDLE TONG

Catalog Number 90-1019

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

We have requested additional information from the customer regarding the procedure and patient involvement.The customer was given a return material authorization form to return the device, however it has not been returned yet.The customer has not provided the lot number or the date of the event.There has been a total of (b)(4) sold of this product code with no additional complaints recorded for this occurrence.A follow up report will be submitted once we have received additional information and evaluated the product.

Event Description

The kleppinger insert broke during a procedure.

Manufacturer Narrative

After multiple attempts to obtain additional information; the lot number, product pictures, or the device itself were not received to properly investigate this complaint.Based on the complaint history of this product and the lack of information obtained, a root cause cannot be determined and no further actions are necessary.This can be seen as the final report.If additional information is obtained that alleges any additional patient involvement or the need for corrective actions, a follow up report will be submitted.

• Brand Name: SYMMETRY SURGICAL
• Type of Device: KLEPPINGER TYPE PADDLE TONG
• Manufacturer (Section D): SYMMETRY SURGICAL INC; 3034 owen drive; antioch TN 37013
• MDR Report Key: 10985107
• MDR Text Key: 221285687
• Report Number: 3007208013-2020-00036
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90-1019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1