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

Catalog Number	0113126
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during laparoscopic hernia plasty procedure, the optifix straight fixation device was used for fixation.It was reported that the barrel insert was detached during use on the patient in the first attempt and the fasteners were not properly fired.The fasteners fell straight out of the device and none of the fasteners were fixated correctly.It was reported the fasteners were fired to a hard structure/bone/cooper ligament.The surgeon requested a new device to complete the procedure.There was no reported patient harm or injury.
Additional Manufacturer Narrative
As reported, barrel insert detachment in optifix straight device.Based on the photo review, the cannula backup tabs are visibly bent, the four crimps on the cannula tip which hold the barrel insert are bent outward and the barrel insert has become detached.Based on the photos and information provided root cause for bent components and detached insert is the result of deploying into bone and coopers ligament.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.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.¿ 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 hernia plasty procedure, the optifix straight fixation device was used for fixation.It was reported that the barrel insert was detached during use on the patient in the first attempt and the fasteners were not properly fired.The fasteners fell straight out of the device and none of the fasteners were fixated correctly.It was reported the fasteners were fired to a hard structure/bone/cooper ligament.The surgeon requested a new device to complete the procedure.There was no reported patient harm or injury.
Additional Manufacturer Narrative
As reported, barrel insert detachment in optifix straight device.Based on the photo review, the cannula backup tabs are visibly bent, the four crimps on the cannula tip which hold the barrel insert are bent outward and the barrel insert has become detached.Based on the photos and information provided root cause for bent components and detached insert is the result of deploying into bone and coopers ligament.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 530 units.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.¿ addendum: h11: this supplemental mdr is submitted to correct the initial reporter details and report source.Updated fields: b4, g3, g6, h2, h10, h11 corrected field: e1 (initial reporter name), e3 (initial reporter occupation), g2 (report source).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: 21607505
• Report Number: 1213643-2025-00099
• Device Sequence Number: 9456829
• Product Code: GDW
• UDI-Device Identifier: 00801741074318
• UDI-Public: (01)00801741074318(17)260428(10)HUJS0989
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K142873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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: 04/28/2026
• Device Catalogue Number: 0113126
• Device Lot Number: HUJS0989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2024
• 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: Male