MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SORBAFIX ENHANCED; STAPLE, IMPLANTABLE

Catalog Number 0113116

Device Problem Crack (1135)

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

Event Date 03/29/2022

Event Type  malfunction  

Event Description

As reported per the medwatch #(b)(4): "patient was having a surgical procedure ¿laparoscopic umbilical hernia repair with mesh¿.During the procedure, the sorbafix fired correctly the first few times and then made a loud crack noise.The surgeon stopped using piece of equipment and removed it for evaluation.Upon inspection, it was noted to have a crack.Removed from the sterile field.Md aware.New sorbafix was opened and finished procedure.No harm noted.Fda safety report id # (b)(4).".

Manufacturer Narrative

As reported, the bard/davol sorbafix enhanced fixation device fired correctly and then cracked.There was no reported patient injury.The information provided is limited to the maude event report.Contact information was not provided, therefore, we are unable to request additional information.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of 770 units released for distribution in (b)(6),2021.The precautions section of the instructions-for-use (ifu) supplied with the device states "care should be taken not to use excessive counterpressure as this may damage the distal tip of the device as well as the mesh and/or tissue¿.

• Brand Name: SORBAFIX ENHANCED
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14434302
• MDR Text Key: 292040448
• Report Number: 1213643-2022-00230
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741016707
• UDI-Public: (01)00801741016707
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 0113116
• Device Lot Number: HUEX2403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other