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

Catalog Number	0113330
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the bard/davol optifix at fixation device was used to fixate a mesh around cooper's ligament and the device deployed broken fasteners.The subject device was discarded by the user facility.Based on the available information and without having the sample available for investigation, we are unable to determine a definitive root cause for the reported event.However, it is possible that the event occurred due to the attempt to fixate into a hard structure.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.The precautions section 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¿ and ¿insertion of fasteners is possible into some collagenous structures such as ligaments and tendons but is not possible directly into bone or cartilage.This may damage the device and result in compromised fixation strength.¿ the date of event is estimated based on the date of awareness of the reported event.Should additional information be provided, a supplemental mdr will be submitted.Not returned - sample discarded.
Event or Problem Description
As reported, during a laparoscopic inguinal hernia repair procedure, a bard/davol optifix at fixation device was used to fixate an unknown mesh around cooper's ligament.As reported, the fasteners deployed broken and were removed from the patient's body.The device was dry fired outside the patient's body and released broken fasteners also noted was that the tip of the device was slightly curved.As reported, another bard/davol optifix at device was used to complete the case without any issues.There was no reported patient injury.

• Brand Name: OPTIFIX AT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12219574
• Report Number: 1213643-2021-20196
• Device Sequence Number: 4137051
• Product Code: GDW
• UDI-Device Identifier: 00801741136566
• UDI-Public: (01)00801741136566
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0113330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other