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

Catalog Number	0113127
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during laparoscopic inguinal hernia repair procedure, the surgeon tried to fixate the 3dmax light mesh using optifix fixation device.It was reported that the device deployed broken fastener where it was fixed to the pubic bone on both sides of the internal inguinal hernia and it was removed from patient's body.It was reported that three fasteners were successfully released from the device and none of them was fixate into the mesh.It was reported that the device deployed fastener normally other than hard structure and the procedure was completed by using another company device.There was no reported patient injury.This file represents device#: 2.
Additional Manufacturer Narrative
As reported, optifix fixation device deployed broken fastener.Based on the information provided the most probable root cause for the reported issue is the attempted deployment into bone.The subject device is reported to be available, however has yet to be returned.Review of manufacturing records confirms product was manufactured to specification.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.The precautions section states, ¿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.¿ this mdr represents the optifix straight (device#: 2).An additional mdr was submitted to represent optifix straight (device#: 1).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.
Event or Problem Description
As reported, during laparoscopic inguinal hernia repair procedure, the surgeon tried to fixate the 3dmax light mesh using optifix fixation device.It was reported that the device deployed broken fastener where it was fixed to the pubic bone on both sides of the internal inguinal hernia and it was removed from patient's body.It was reported that three fasteners were successfully released from the device and none of them was fixate into the mesh.It was reported that the device deployed fastener normally other than hard structure and the procedure was completed by using another company device.There was no reported patient injury.This file represents device #2.
Additional Manufacturer Narrative
As reported, optifix fixation device deployed broken fastener.Based on the information provided the most probable root cause for the reported issue is the attempted deployment into bone.The subject device is reported to be available, however has yet to be returned.Review of manufacturing records confirms product was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Evaluation of the returned sample finds for bent guide wire and backup tabs.The reported deployment of a broken fastener is known result of bent guide wire and bent backup tabs.The components are found to be bent from applied forces when in use.No manufacturing anomies were found.The instructions-for-use 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.¿ updated fields.This supplemental mdr represents the optifix straight (device #2).An additional supplemental mdr was submitted to represent the optifix straight (device #1).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.

• Brand Name: OPTIFIX STRAIGHT
• 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: 21284592
• Report Number: 1213643-2025-00031
• Device Sequence Number: 9355258
• Product Code: GDW
• UDI-Device Identifier: 00801741074325
• UDI-Public: (01)00801741074325(17)251228(10)HUJN2116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 12/28/2025
• Device Catalogue Number: 0113127
• Device Lot Number: HUJN2116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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