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	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the fasteners of the optifix straight fixation device broke.As reported the device fastener will be returned for evaluation; however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made at this time.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.The reported event that the device deployed broken fasteners is confirmed by the broken fastener received with the return.Sample evaluation is inconclusive as the actual device was not returned.Based on the information available and without having the sample to evaluate, no conclusions can be made.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 procedure on (b)(6) 2026, the optifix straight fixation device malfunctioned, and no fasteners got fired; they were damaged.Reportedly, the broken fasteners were collected.There was no patient injury.
Event or Problem Description
As reported, during a procedure on (b)(6) 2026, the optifix straight fixation device malfunctioned, and no fasteners got fired; they were damaged.Reportedly, the broken fasteners were collected.There was no patient injury.
Additional Manufacturer Narrative
As reported, the fasteners of the optifix straight fixation device broke.As reported the device fastener will be returned for evaluation; however, at this time has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made at this time.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.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: 24456018
• Report Number: 1213643-2026-00230
• Device Sequence Number: 15786829
• Product Code: GDW
• UDI-Device Identifier: 00801741074325
• UDI-Public: (01)00801741074325(17)270428(10)HUKS1741
• 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): 03/02/2026

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
• Device Lot Number: HUKS1741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• 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