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

Catalog Number	0113330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2022, the surgeon used a bard/davol optifix at fixation device.It is reported that the surgeon attempted to use the articulating lever of the fixation device with excessive force.It was reported that the small plastic piece that covers the screw on the lever popped off and fell onto the floor.The piece of plastic was retrieved.A new optifix at device was used to complete the case.There was no patient injury or harm.
Additional Manufacturer Narrative
It was reported that the small plastic piece that covers the housing screw on the articulating lever popped off.Note, there is no plastic piece that cover the housing screw on this device.Initial evaluation of the sample finds a piece of the articulation lever near the housing screw had broken off on one side.The same break occurred on the opposite side of the articulation lever but there was no material breaking free from the lever.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 440 units released for distribution in june 2022.Sample evaluation in process.
Additional Manufacturer Narrative
It was reported that the small plastic piece that covers the housing screw on the articulating lever popped off.Note, there is no plastic piece that cover the housing screw on this device.Initial evaluation of the sample finds a piece of the articulation lever near the housing screw had broken off on one side.The same break occurred on the opposite side of the articulation lever but there was no material breaking free from the lever.Review of the returned sample is currently ongoing, as such no conclusions have been made.When the sample evaluation is completed, a supplemental mdr will be submitted.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june 2022.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of sample evaluation.Evaluation of the returned sample found material damage in one side of the articulation lever, for which the material section broke off of the device near the housing screw, and material breakage on the opposite side of the articulation lever in the region near the housing screw as reported.No manufacturing anomalies were found.Based on the sample evaluation and information provided, the reported event is confirmed.Root cause for damage to the articulation lever is the result excessive force by the first time user as was reported.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : sample evaluated.
Event or Problem Description
As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2022, the surgeon used a bard/davol optifix at fixation device.It is reported that the surgeon attempted to use the articulating lever of the fixation device with excessive force.It was reported that the small plastic piece that covers the screw on the lever popped off and fell onto the floor.The piece of plastic was retrieved.A new optifix at device was used to complete the case.There was no patient injury or harm.

• 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
• 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: 15395270
• Report Number: 1213643-2022-00618
• Device Sequence Number: 4905525
• Product Code: GDW
• UDI-Device Identifier: 00801741136566
• UDI-Public: (01)00801741136566
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K191287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2022

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: 04/28/2024
• Device Catalogue Number: 0113330
• Device Lot Number: HUGS2506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown