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

Catalog Number	0113127
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during one inguinal hernia repair procedure, the fasteners of optifix fixation device were not fixating (device #1, #2 - 15 count, device #3 - 30 count).It was reported that surgeon was an experienced user of the device but had issues this time during use.As reported, the area of fixation was not any bone or ligament and the fasteners that were not fixating were removed from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the fasteners of optifix fixation device were not fixating.Based on the information provided to date and without having the sample to evaluate, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.This mdr represents the optifix (device #1).An additional mdrs were submitted to represent the optifix (device #2, #3).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: 21179496
• Report Number: 1213643-2024-00619
• Device Sequence Number: 8630233
• Product Code: GDW
• UDI-Device Identifier: 00801741074325
• UDI-Public: (01)00801741074325(17)250628(10)HUHU1235
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142873
• 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
• Report Date (Section B): 12/31/2024

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: 06/28/2025
• Device Catalogue Number: 0113127
• Device Lot Number: HUHU1235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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