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

Catalog Number	0113126
Medical Device Problem Codes	Break (1069); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic hernia repair, the optifix device did not fire the fastener at first shot, deployed broken fastener during the second fire, the third fastener did not fixate correctly, and subsequent fasteners got stuck in device.It was reported that another device was used to complete the procedure, no loose fasteners were left inside the body, and no medical/surgical intervention was performed.There was no patient harm.
Additional Manufacturer Narrative
As reported, the first fastener of the optifix device did not come out, second fastener came out broken, third fastener did not fixate.Review of photos of the used device provided finds for bent components at the distal tip.The failure modes reported are known result.The components most likely bent due to forces applied while in use.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 525 units.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: 20863432
• Report Number: 1213643-2024-00577
• Device Sequence Number: 21006105
• Product Code: GDW
• UDI-Device Identifier: 00801741074318
• UDI-Public: (01)00801741074318(17)251128(10)HUHZ1054
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 11/28/2025
• Device Catalogue Number: 0113126
• Device Lot Number: HUHZ1054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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