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

Catalog Number	0113330
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the optifix at fastener came out backwards while fixating the mesh.The subject product was not returned for evaluation.An intra-operative photo was provided.Depicted in the photo is a loose fastener from the optifix at; the head of the fastener appears to be flush with the mesh.Evaluation of the photo is inconclusive.Based on the photo evaluation and not having the sample returned for review, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in april, 2021.The precautions section of the instructions-for-use supplied with the device states, ¿if the fastener does not deploy properly, remove the device from the patient and test the device in gauze to ensure proper fastener deployment.Once proper fastener deployment is confirmed, the device may be reinserted into the patient.¿.
Event or Problem Description
As reported, during laparoscopic inguinal hernia repair procedure on (b)(6) 2021 a bard/davol optifix at, 30 count fixation device was used.After firing 7 staples correctly, one of the fasteners came out backwards while fixating the mesh.The rest of the fasteners fired were fine.The fastener reported to have deployed backward was removed from the patient.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: 12281504
• Report Number: 1213643-2021-20230
• Device Sequence Number: 17493652
• Product Code: GDW
• UDI-Device Identifier: 00801741136566
• UDI-Public: (01)00801741136566
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K191287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2021

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 Expiration Date: 01/28/2023
• Device Catalogue Number: 0113330
• Device Lot Number: HUFP1797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/05/2021
• 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