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

Catalog Number 0113115

Device Problems Break (1069); Unintended Ejection (1234)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

As reported, during a laparoscopic umbilical hernia repair procedure on (b)(6) 2022, the bard/davol sorbafix fixation device was used while fixating a bard/davol ventralex mesh.As reported, the first few fasteners were fine then the device malfunctioned and began to release two fasteners at a time.It was reported that the fasteners were removed, and another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

As reported, the sorbafix fixation device deployed two fasteners at a time.The subject device is returned for evaluation.Broken fasteners were also received.A functional evaluation was unable to be performed as the device was received empty.There is no indication the device would deploy broken fasteners.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed the reported event was confirmed and the most probable root cause for a broken fastener to present in use is the result of forces applied during user / device interface.To date, this is the only reported complaint for this manufacturing lot.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for successful fastener delivery.The precautions section of the ifu supplied with the device states, ¿if the fastener does not deploy properly, remove the device from the patient and test the device in air to ensure proper fastener deployment.Once proper fastener deployment is confirmed, the device may be reinserted into the patient.¿ sample evaluated.

• 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: 15812510
• MDR Text Key: 304361731
• Report Number: 1213643-2022-00736
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741016691
• UDI-Public: (01)00801741016691
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0113115
• Device Lot Number: HUGT1401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other