MAUDE Adverse Event Report: SYMMETRY SURGICAL SYMMETRY SURGICAL; SYMMETRY FORCEPS, WEIL-BLAKESLEY, STRAIGHT, THRU-CUTTING, 7 1/4 INCH

Catalog Number 63-6600

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility alleges in their report that the forceps "was being used by surgeons.The tip of the forceps broke but was able to be retrieved." according to the user facility, the device is not available to be returned for evaluation.Limited information has been made available at this time.However, we do have the user facility report that was mailed to us from the fda.We will continue to follow up with the user for additional information.This can been seen as the final report.If additional information is received that alleges additional patient involvement or need for corrective actions, a follow up report will be submitted.

Event Description

The reporter alleged: "thru-cut straight forceps was being used by surgeons.The tip of the forceps broke, but was able to be retreived.".

• Brand Name: SYMMETRY SURGICAL
• Type of Device: SYMMETRY FORCEPS, WEIL-BLAKESLEY, STRAIGHT, THRU-CUTTING, 7 1/4 INCH
• Manufacturer (Section D): SYMMETRY SURGICAL; 3034 owen dr; antioch TN 37027
• Manufacturer (Section G): SYMMETRY SURGICAL; 3034 owen dr; antioch TN 37013
• Manufacturer Contact: andy ferrell ; 3034 owen dr; antioch, TN 37013 ; 6159645553
• MDR Report Key: 11787642
• MDR Text Key: 268319262
• Report Number: 3007208013-2021-00016
• Device Sequence Number: 1
• Product Code: KAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 63-6600
• Device Lot Number: CEAU05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 117