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	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a transabdominal preperitoneal (tapp) procedure, after fixating the mesh successfully during the initial 5 shots, the optifix device handle became stiff on the sixth shot while fixating in cooper's ligament and the fastener came out cracked.It was reported that the cracked (broken) fastener was removed, and the seventh fastener did not come out therefore another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, the optifix device deployed broken fasteners while fixating in cooper's ligament and was removed from patient's body.The subject device is said to be available however, at this time it has not been received.Based on the information provided the most probable cause for the reported fastener break is the result of forces applied in use while firing into an underlying hard structure the cooper's ligament.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use supplied with the device adequately describes 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.
Additional Manufacturer Narrative
As reported, the optifix device deployed broken fasteners while fixating in cooper's ligament and was removed from patient's body.The subject device is said to be available however, at this time it has not been received.Based on the information provided the most probable cause for the reported fastener break is the result of forces applied in use while firing into an underlying hard structure the cooper's ligament.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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: 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 while firing into an underlying hard structure the cooper's ligament.No manufacturing anomies were found.Updated fields: b4, d9, g3, g6, h2, h3, h6, h10.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 a transabdominal preperitoneal (tapp) procedure, after fixating the mesh successfully during the initial 5 shots, the optifix device handle became stiff on the sixth shot while fixating in cooper's ligament and the fastener came out cracked.It was reported that the cracked (broken) fastener was removed, and the seventh fastener did not come out therefore another device was used to complete the procedure.There was no patient injury.

• 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: 21283002
• Report Number: 1213643-2025-00029
• Device Sequence Number: 15411680
• Product Code: GDW
• UDI-Device Identifier: 00801741074325
• UDI-Public: (01)00801741074325
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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 Catalogue Number: 0113127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• 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
• 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